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

Completed

• Conditions: Adnexal Tumor
• Interventions: Other: Correlation of MRI results with clinical characteristics of the adnexal mass

• Registration Number: NCT02742870
• Lead Sponsor: Brugmann University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-08
• Study First Submitted: 2016-04-01
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-19
• Primary Completion: 2019-01-30
• Study Completion: 2019-01-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with MRI pelvic imaging	Correlation of MRI results with clinical characteristics of the adnexal mass	Women over 18 years old, having undergone a magnetic resonance imaging of the pelvis within the CHU Brugmann Hospital

Primary Outcome Measures

Name	Time	Method
MRI Adnex score	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)
IOTA ultrasound classification	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)
Apparent diffusion coefficient (ADC) of the adnexal mass volume (mm2/sec)	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.
Anatomo-pathology classification - histological type	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.
Anatomo-pathology classification - malignancy grading of tumor	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.

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium