Skip to main content
OpenTrials
Completed

NCT Number: NCT02792959

Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging

This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonié

Bordeaux, Gironde, 33076, France

About this study

This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent. It is a single center evaluation of the study treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Epithelial ovarian carcinoma, fallopian tube, or primary peritoneal carcinoma FIGO IIIC-IV histologically confirmed by biopsy and documented stage and untreated
  • Pre-treatment abdominopelvic PET-CT and MRI within 4 weeks before neoadjuvant chemotherapy.
  • During laparoscopy performed by an experienced surgeon in the treatment of ovarian cancer, patient considered ineligible for tumor cell kill at the outset.
  • A life expectancy of greater than three months
  • An eligible patient for Paclitaxel and Carboplatine based chemotherapy.
  • Membership of a social security scheme
  • Patient information and signed, dated written informed consent

Exclusion criteria

  • Pre-treated using chemotherapy, radiology, or surgery for an ovarian cancer.
  • Contraindication to MRI with the injection of contrast product, i.e, the first three months pregnancy, claustrophobia, major allergic antecedents, pacemaker, some surgery clips, some heart valves, cava filter, implanter pumps, cochlear implants, metallic extraneous malter.
  • Uncontrolled diabetes
  • Pregnancy and nursing
  • Other uncontrolled medical conditions as thyroid pathology, neuropsychiatric disease, infection, coronary insufficiency or grade 3 - 4 heart disease established by association "New York Heart"
  • Patient deprived of liberty and legally protect adult, or not in position to give consent.

Treatment and study plan

Functional Imaging previous the second course

Device

Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1

Functional Imaging previous the surgery

Device

Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval

Primary outcomes

  1. Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

    Time frame: Pre-therapeutic

    Individual intra-class correlation coefficients by location (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  2. Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

    Time frame: Pre-therapeutic

    Average intra-class correlation coefficients(Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography.

    The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  3. Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

    Time frame: Pre-therapeutic

    Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography.

    The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  4. Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

    Time frame: Pre-therapeutic

    Average intra-class correlation coefficients (Absolute agreement) arepresented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography.

    The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  5. Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

    Time frame: Pretherapeutic

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging.

    The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  6. Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

    Time frame: Pretherapeutic

    Average intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging.

    The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  7. Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

    Time frame: After one cycle of chemotherapy, 3 weeks

    Individual Intra-class Correlation (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET).

    The functional imaging Positron Emission Tomography (PET) will be interpreted twice by radiologist and nuclear medicine specialist.

  8. Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

    Time frame: After one cycle of chemotherapy, 3 weeks

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET) .

    The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  9. Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

    Time frame: After one cycle of chemoterapy, 3 weeks

    Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET).

    The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  10. Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

    Time frame: After one cycle of chemotherapy, 3 weeks

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET).

    The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  11. Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

    Time frame: After one cycle of chemotherapy, 3 weeks

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI).

    The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  12. Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

    Time frame: After one cycle of chemotherapy, 3 weeks

    Average intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI).

    The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  13. Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

    Time frame: After four cycles of chemotherapy, 12 weeks

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET) .

    The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  14. Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

    Time frame: After four cycles of chemotherapy, 12 weeks

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET).

    The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  15. Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

    Time frame: After four cycles of chemoterapy, 12 weeks

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (MTV).

    The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  16. Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by Location

    Time frame: After four cycles of chemotherapy, 12 weeks

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET).

    The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  17. Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

    Time frame: After four cycles of chemotherapy, 12 weeks

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI).

    The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  18. Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

    Time frame: After four cycles of chemotherapy, 12 weeks

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter of ADC functional imaging Magnetic Resonance Imaging (MRI).

    The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.

  19. Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

    Time frame: Pre-therapeutic

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter ADC of functional imaging positron emission tomography (PET).

    The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  20. Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

    Time frame: Pre-therapeutic

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET) .

    The imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  21. Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

    Time frame: Pre-therapeutic

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters functional imaging Positron Emission Tomography (MTV).

    The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  22. Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

    Time frame: Pre-therapeutic

    Average Intra-class Correlation Coefficients by Location (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters MTV of functional imaging Positron Emission Tomography.

    The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  23. Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

    Time frame: Pretherapeutic

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI).

    The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  24. Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

    Time frame: Pretherapeutic

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI) .

    The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  25. Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

    Time frame: After one cycle of chemoterapy, 3 weeks

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUV max of functional imaging positron emission tomography (PET).

    The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  26. Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

    Time frame: After once cycle of chemoterapy, 3 weeks

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET).

    The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  27. Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

    Time frame: After one cycle of chemoterapy, 3 weeks

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET).

    The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  28. Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

    Time frame: After once cycle of chemotherapy, 3 weeks

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET).

    The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  29. Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

    Time frame: After one cycle of chemotherapy, 3 weeks

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI).

    The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  30. Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

    Time frame: After one cycle of chemotherapy, 3 weeks

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI).

    The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  31. Individual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location

    Time frame: After four cycles of chemoterapy, 12 weeks

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET).

    The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  32. Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location

    Time frame: After four cycles of chemoterapy, 12 weeks

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET).

    The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  33. Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location

    Time frame: After four cycle of chemoterapy, 12 weeks

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET).

    The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  34. Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location

    Time frame: After four cycles of chemotherapy, 12 weeks

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET).

    The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  35. Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location

    Time frame: After four cycles of chemotherapy, 12 weeks

    Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI).

    The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

  36. Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location

    Time frame: After four cycles of chemotherapy, 12 weeks

    Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI).

    The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.

Secondary outcomes

  1. Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)

    Time frame: After one cycle of chemotherapy, 3 weeks

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse.

    The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations.

    The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations.

    Relative variations has been calculated as the difference between the values collected after 1 cycle of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.

  2. Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)

    Time frame: After four cycles of chemotherapy, 12 weeks

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse.

    The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations.

    The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations.

    Relative variations has been calculated as the difference between the values collected after 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.

  3. Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125

    Time frame: After one and four cycle(s) of chemotherapy (after 3 and 12 weeks)

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.

    The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations.

    The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations.

    Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.

  4. Complete Surgery Resection

    Time frame: Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery

  5. Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1

    Time frame: After one cycle of chemotherapy, 3 weeks

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.

    Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

  6. Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1

    Time frame: After four cycles of chemotherapy, 12 weeks

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.

    RRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

  7. Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1

    Time frame: After four cycles of chemotherapy, 12 weeks

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.

    Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

  8. Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1

    Time frame: After one cycle of chemotherapy, 3 weeks

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.

    Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

  9. Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1

    Time frame: After one cycle of chemotherapy, 3 weeks

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.

    Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

  10. Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1

    Time frame: After four cycles of chemotherapy, 12 weeks

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.

    Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

  11. Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1

    Time frame: After one cycle of chemotherapy, 3 weeks

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.

    Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

  12. Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1

    Time frame: After four cycles of chemotherapy, 12 weeks

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.

    Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

  13. Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1

    Time frame: After one cycle of chemotherapy, 3 weeks

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.

    Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

  14. Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1

    Time frame: After four cycles of chemotherapy, 12 weeks

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.

    Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

  15. Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1

    Time frame: After one cycle of chemotherapy, 3 weeks

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.

    Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

  16. Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1

    Time frame: After four cycles of chemotherapy, 12 weeks

    In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses.

    Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).

  17. Peritoneal Extent Assessed by Fagotti Score Using MRI Data

    Time frame: Pre-therapeutic

    The Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread.

    The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases.

    The sum of subscale values corresponds to Fagotti score.

  18. Peritoneal Extent Assessed by Fagotti Score Using MRI Data

    Time frame: Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery

    TThe Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread.

    The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases.

    The sum of subscales corresponds to Fagotti score.

  19. Overall Survival

    Time frame: 10 months

  20. Progression-free Survival as Per RECIST v1.1

    Time frame: 9, 13, 14 months

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Collaborators

  • Ligue contre le cancer, France
  • Roche Pharma AG

Registry information

Official study title

Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging (Fusion MRI and FDG-PET-CT)

Acronym: IMOVA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2016
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.