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Completed

NCT Number: NCT02275273

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

The goal of this study is to correlate the pelvic magnetic resonance imagery characteristics of adnexal masses with their anatomopathological characteristics.

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Key information

Conditions

Adnexal Masses

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 27, 2014
Registry last updated
May 18, 2015

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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