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NCT Number: NCT02742870

Diffusion MRI (Magnetic Resonance Imaging) Using ADC (Apparent Diffusion Coefficient) Histograms in the Evaluation of Adnexal Tumor Aggressiveness

Diffusion-weighted sequences have been routinely performed for years to study the pelvis. They have been so far mainly qualitatively interpreted, that is to say as the absence or presence of an hypersignal at a high b value. The quantitative analysis involves placing the region of interest (ROI) on the apparent diffusion coefficient (ADC) map. The manual placement is very operator dependent, and does not reflect the entirety of the studied mass.

In all fields of Magnetic Resonance Imaging, a multiparametric approach integrating diffusion analysis is flourishing. However, the quantitative analysis of the diffusion is still little studied for tumor heterogeneity analysis, including in the gynecological sphere.

The investigators will therefore retrospectively evaluate the apparent diffusion coefficient (ADC) histograms, extracted from the diffusion ponderation sequences, of the magnetic imaging resonance analysis of adnexal masses and confront the results with the anatomo-pathology results, for patients having undergone surgery, and/or with the clinical and imagery follow-up results.

The investigators goal will be to improve the performance of conventional MRI in the analysis of adnexal masses.

The expected benefits of this study are:

* a correlation with the histology analysis or the clinical monitoring * an improved prediction of the malignancy of the tumor * an improved magnetic resonance imaging performance for adnexal masses, with better surgical therapeutic management * an improved negative predictive value, thereby ultimately limiting unnecessary surgical explorations.

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Key information

Conditions

Adnexal Tumor

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women aged over 18 years old, having undergone magnetic resonance imaging of the pelvis within the CHU Brugmann hospital.

Exclusion criteria

  • Examinations without diffusion sequences
  • Examinations with incomplete diffusion sequences
  • Absence of anato-pathologic result, or absence of gynecological clinical/imaging follow-up.

Treatment and study plan

Correlation of MRI results with clinical characteristics of the adnexal mass

Other

Quantitative analysis of the magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens), based on the ADC cartography.The post-processing will be realized with the Syngo Onco Care application of Siemens, that allows an histogram analysis of the ADC of all sections of the adnexal mass, as opposed to a section per section approach with the Region of Interest (ROI) method.

The results will be correlated with the clinical data regarding the adnexal mass: anatomo-pathology status (malignancy and aggressiveness of the tumor) and the gynecological follow-up.

Primary outcomes

  1. Apparent diffusion coefficient (ADC) of the adnexal mass volume (mm2/sec)

    Time frame: From 01/01/2015 till the end of study (2 years)

    Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.

  2. Anatomo-pathology classification - histological type

    Time frame: From 01/01/2015 till the end of study (2 years)

    Follow-up of the patients that did undergo surgery: histological type of tumor. The histological type of the tumor will be determined by the Anatomo-Pathology Department of the CHU Brugmann hospital, according to standard of care.

  3. MRI Adnex score

    Time frame: From 01/01/2015 till the end of study (2 years)

    Follow-up of the patients that did not undergo surgery: medical imaging classification of the adnexal mass (MRI Adnex score)

  4. IOTA ultrasound classification

    Time frame: From 01/01/2015 till the end of study (2 years)

    Follow-up of the patients that did not undergo surgery: transvaginal ultrasound classification of the adnexal masse (IOTA ultrasound classification)

  5. Anatomo-pathology classification - malignancy grading of tumor

    Time frame: From 01/01/2015 till the end of study (2 years)

    Follow-up of the patients that did undergo surgery: malignancy grading of the adnexal mass according to FIGO classification.

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

Diffusion Magnetic Resonance Imaging Using ADC (Apparent Diffusion Coefficient) Histograms in the Evaluation of Adnexal Tumor Aggressiveness

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2016
Registry last updated
Jan 18, 2020

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.

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