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NCT Number: NCT04008095

Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer

A lot of studies have demonstrated the prognostic value of post therapy 18F-FDG PET/CT in the management of uterine cervical cancer. Post therapy 18F-FDG PET/CT is usually requested by a lot of clinicians.

Whereas 18F-FDG PET/CT is useful for prognosis in the follow-up, data are yet insufficient to clearly establish a formal recommendation.

This prospective multicenter observational study will evaluate the interest of post therapy 18F-FDG PET/CT in clinical management (within 2 months of treatment) in patients with cervical cancer at an advanced stage.

Main outcome :

The therapeutic impact of post therapy 18F-FDG PET/CT (within 2 months after the end of therapy) will be evaluated on the complete results included MRI.

Investigators will compare :

* decision of clinicians without 18F-FDG PET/CT results * and decision of clinicians knowing entire results included results of 18F-FDG PET/CT.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHRU de Brest (Hôpital Morvan), Brest, France

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About this study

With approximately 3000 new cases estimated in France on 2017, the uterine cervical cancer is the twelfth cancer cause in women, responsible for 1000 deaths per year.

Management of uterine cervical cancer is well defined before treatment, especially for imaging including systematically pelvic MRI and 18F-FDG PET/CT.

A lot of studies have demonstrated the prognostic value of post therapy 18F-FDG PET/CT, due to semi quantitative parameters study, like the SUV max and delta SUV between pre and post therapy 18F-FDG PET/CT or qualitatively with the persistence of positive 18F-FDG PET/CT at the end of therapy.

Whereas 18F-FDG PET/CT is useful for prognosis in the follow-up, data are yet insufficient to clearly establish a formal recommendation.

Nevertheless, post therapy 18F-FDG PET/CT is still usually requested by a lot of clinicians.

Furthermore, the group of Parisian public hospital (AP-HP) has established a guide for the management of cervical cancer (2016) and recommends to systematically realize a 18F-FDG PET/CT after treatment for advanced cervical cancer.

Main purpose :

Evaluate the role of post therapy 18F-FDG PET/CT in clinical management (within 2 months of treatment) in patients with uterine cervical cancer at an advanced stage.

Main outcome :

The therapeutic impact of post therapy 18F-FDG PET/CT (within 2 months after the end of therapy) will be evaluated on the complete results included MRI.

Investigators will compare

  • decision of clinicians without 18F-FDG PET/CT results
  • and decision of clinicians knowing entire results included results of 18F-FDG PET/CT.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient old ≥ 18 years
  • Uterine cervical cancer with locally-advanced (FIGO 2019 IB3 to IVA)
  • Histology: squamous cell carcinoma and adenocarcinoma
  • Feasibility of a curative treatment
  • Having formulated a non-opposition

Exclusion criteria

  • Minor patient < 18 years
  • Pregnancy or breastfeeding
  • Other type of tumor than squamous cell carcinoma and adenocarcinoma
  • FIGO 2019 < IB3 or > IVA
  • Non-eligibility for the examination
  • Contraindication to MRI and PET/CT
  • Previous history of cancer
  • Refusal of participation

Treatment and study plan

Primary outcomes

  1. The therapeutic impact of post therapy 18F-FDG PET/CT (within 2 months after the end of therapy) will be evaluated on the complete results included MRI.

    Time frame: Validated by six months follow up

    Investigators will compare

    • decision of clinicians without 18F-FDG PET/CT results
    • and decision of clinicians knowing entire results included results of 18F-FDG PET/CT.

    Gold Standard for the diagnosis of progression will be based on the conclusions of multi-disciplinary staff ruling on the results of composite data, including clinical examination, biology, histopathology, morphological imaging (MRI), functional imaging (PET/CT) and 6-month follow-up.

  2. collection of the two décisions of RCP

    Time frame: Validated by six months follow up

    To make statistical analysis possible, the collection of the two decisions will be chosen from three cases of care envisaged below:

    • Complete therapeutic response
    • Equivocal response: doubt about the presence of residual disease.
    • Strong suspicion of residual disease and/or progression Then, we will collect a percentage of patients with rightly changes on management induced by the result of the PET-CT at 18F-FDG.

Secondary outcomes

  1. Physiological analysis parameter

    Time frame: 24 months follow up

    Diagnostic performances of PET/CT, Sensibility, Specificity, positive predictive value, negative predictive value

  2. Prognostic factors

    Time frame: 24 months follow up

    Especially dynamic parameters (SUV max ...) and search for a statistical correlation between this value and PFS and OS.

  3. Physiological analysis, hotspots study

    Time frame: 24 months follow up

    Hotspots study - Search for a density intersection between the local site residual disease of post-therapeutic 18F-FDG PET/CT and maximum-fixing tumor sites in 18F-FDG PET/CT Baseline.

  4. Physiological analysis, hotspots study

    Time frame: 24 months follow up

    Hotspots study - Search maximum-fixing tumor sites in 18F-FDG PET/CT Baseline

  5. Physiological analysis, hotspots study

    Time frame: 24 months follow up

    Assess the dosimetry of an escalation of the dose on these hotspots.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Evaluation of the Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer at an Advanced Stage. Multicenter Prospective Observational Study

Acronym: COLTEP

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2019
Registry last updated
May 20, 2026

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

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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.

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