Adnexal Masses : Correlation Between MRI (Magnetic Resonance Imagery) and Anatomopathology

May 15, 2015 updated by: Carine DE PREZ, Brugmann University Hospital
The goal of this study is to correlate the pelvic magnetic resonance imagery characteristics of adnexal masses with their anatomopathological characteristics.

Study Overview

Status

Completed

Conditions

Detailed Description

Several studies have identified the characteristics of adnexal masses obtained by different imaging techniques (echography, scanner and magnetic resonance) and corresponding to benign, borderline or malign masses (Kurtz et al 1999, Grabowska-Derlatka et al, 2013, Tanaka et al 2011, Asch et al 2008).

Recently, studies have even established ecographic and magnetic resonance imaging scores combining these characteristics (Thomassin-Naggara 2013, Timmerman 2005), some of these characteristics being considered as more suspect than others.

However, these studies have considered adnexal masses in their globality only and to our knowledge, none have correlated their imagery characteristics with their precise anatomopathology characteristics.

The goal of this study is thus to correlate the pelvic magnetic resonance imagery characteristics of the adnexal masses with their anatomopathology characteristics, in order to add complementary information for the future management of masses that are defined as borderline according to imagery.

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women with adnexal masses, with a planned pelvic magnetic resonance imagery and a planned adnexectomy within the institution, having signed the informed consent form.

Description

Inclusion Criteria:

- Every woman aged 18 years and more, with a planned pelvic magnetic resonance imagery and a planned adnexectomy within the institution.

Exclusion Criteria:

- Insufficient technical quality of the pelvic magnetic resonance imagery images or of the anatomopathological analysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with adnexal masses
Every patient that are at least 18 years old with a planned pelvic magnetic resonance imagery and an adnexectomy within the institution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RECIST criteria
Time Frame: at MRI diagnosis
MRI imaging (standard protocol for ovarian pathology). The MRI will be realised on a 3.0T instrument (Philips Medical Systems, Best, The Netherlands). The patient will be placed in dorsal decubitus with an antenna placed at the pelvic level. Just before the examination, Buscopan IV will be injected. The initial protocol will consist in a localisation examination followed by a standard protocol for ovarian pathologies, meaning a SE T2WI in the three plans, an axial diffusion sequence and a pondered T1 sequence (T1 dynamic contrast imaging). The total examination time will be 20 minutes on average.
at MRI diagnosis
Percentage of epithelial and conjunctive zones in the adnexal mass obtained by surgery
Time Frame: 24h after MRI diagnosis
The anatomopathologist will contact the surgeons when an adnexectomy is programmed. A detailed macroscopic description is realized (photographies of the external capsule) and the fragment is oriented according to 6 axes (superior, inferior, external, internal, anterior, posterior) with permanent tissues marking dyes. The piece will be sectioned in 1cm slices, a picture of each one being taken. The piece will be fixed in formol and embedded in paraffin. Slices will be made using a RM 2235 Leica Microtome and colored with hematoxylin/eosin, for examination by the anatomopathologist. The radiologist and the anatomopathologist will select, by consensus, interest zones that will be examined with an accredited microscope (ISO9001 accreditation). Several parameters such as the percentage of epithelial and conjunctive zones will be observed, described and semi-quantified. Immunomarkings will be realized if necessary, according to the criteria described in the ISO9001 accreditation files.
24h after MRI diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brugmann University Hospital

Investigators

  • Study Director: Carine De Prez, Chef de service, CHU Brugmann
  • Principal Investigator: Françoise HULET, MD, CHU Brugmann

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

June 27, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Estimate)

May 18, 2015

Last Update Submitted That Met QC Criteria

May 15, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Adnexal masses

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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