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

NCT02742870 | Completed

• 1 other identifier: CHUB-MRI-Adnexal Tumor
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Adnexal Tumor

Keywords

Diffusion MRI; ADC histograms; Adnexal tumor

Outcome Measures

Primary Outcomes (5)

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

  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.

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

• Anatomo-pathology classification - histological type

  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.

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

• MRI Adnex score

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

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

• IOTA ultrasound classification

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

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

• Anatomo-pathology classification - malignancy grading of tumor

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

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

Study Arms (1)

Patients with MRI pelvic imaging

Women over 18 years old, having undergone a magnetic resonance imaging of the pelvis within the CHU Brugmann Hospital

Other: Correlation of MRI results with clinical characteristics of the adnexal mass

Interventions

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.

Patients with MRI pelvic imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women having undergone magnetic resonance imaging of the pelvis within the CHU Brugmann hospital.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (2)

• Thomassin-Naggara I, Aubert E, Rockall A, Jalaguier-Coudray A, Rouzier R, Darai E, Bazot M. Adnexal masses: development and preliminary validation of an MR imaging scoring system. Radiology. 2013 May;267(2):432-43. doi: 10.1148/radiol.13121161. Epub 2013 Mar 6.

  PMID: 23468574 BACKGROUND

• Just N. Improving tumour heterogeneity MRI assessment with histograms. Br J Cancer. 2014 Dec 9;111(12):2205-13. doi: 10.1038/bjc.2014.512. Epub 2014 Sep 30.

  PMID: 25268373 BACKGROUND

Study Officials

• Mieke Cannie, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

• Nathalie Hottat, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 19, 2016
• Study Start: March 8, 2016
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

BE (1)