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

NCT02275273 | Completed DMC

• 1 other identifier: Adnexal masses
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adnexal Masses

Keywords

Adnexal Masses; Magnetic Resonance Imaging; Anatomopathology

Outcome Measures

Primary Outcomes (2)

• RECIST criteria

  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

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (6)

• Kurtz AB, Tsimikas JV, Tempany CM, Hamper UM, Arger PH, Bree RL, Wechsler RJ, Francis IR, Kuhlman JE, Siegelman ES, Mitchell DG, Silverman SG, Brown DL, Sheth S, Coleman BG, Ellis JH, Kurman RJ, Caudry DJ, McNeil BJ. Diagnosis and staging of ovarian cancer: comparative values of Doppler and conventional US, CT, and MR imaging correlated with surgery and histopathologic analysis--report of the Radiology Diagnostic Oncology Group. Radiology. 1999 Jul;212(1):19-27. doi: 10.1148/radiology.212.1.r99jl3619.

  PMID: 10405715 BACKGROUND

• Grabowska-Derlatka L, Derlatka P, Palczewski P, Danska-Bidzinska A, Pacho R. Differentiation of ovarian cancers from borderline ovarian tumors on the basis of evaluation of tumor vascularity in multi-row detector computed tomography--comparison with histopathology. Int J Gynecol Cancer. 2013 Nov;23(9):1597-602. doi: 10.1097/IGC.0b013e3182a80a41.

  PMID: 24172096 BACKGROUND

• Tanaka YO, Okada S, Satoh T, Matsumoto K, Saida T, Oki A, Yoshikawa H, Minami M. Solid non-invasive ovarian masses on MR: histopathology and a diagnostic approach. Eur J Radiol. 2011 Nov;80(2):e91-7. doi: 10.1016/j.ejrad.2010.05.032. Epub 2010 Jun 23.

  PMID: 20576386 BACKGROUND

• Asch E, Levine D, Kim Y, Hecht JL. Histologic, surgical, and imaging correlations of adnexal masses. J Ultrasound Med. 2008 Mar;27(3):327-42. doi: 10.7863/jum.2008.27.3.327.

  PMID: 18314510 BACKGROUND

• 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

• Timmerman D, Testa AC, Bourne T, Ferrazzi E, Ameye L, Konstantinovic ML, Van Calster B, Collins WP, Vergote I, Van Huffel S, Valentin L; International Ovarian Tumor Analysis Group. Logistic regression model to distinguish between the benign and malignant adnexal mass before surgery: a multicenter study by the International Ovarian Tumor Analysis Group. J Clin Oncol. 2005 Dec 1;23(34):8794-801. doi: 10.1200/JCO.2005.01.7632.

  PMID: 16314639 BACKGROUND

Study Officials

• Carine De Prez, Chef de service

  CHU Brugmann

  STUDY DIRECTOR

• Françoise HULET, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PMD

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: October 27, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

BE (1)