NCT02275273|CompletedDMC
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Sponsor study identifier
observational
13
1 country
1
Study Start
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)The goal of this study is to correlate the pelvic magnetic resonance imagery characteristics of adnexal masses with their anatomopathological characteristics.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 27, 2014
Actual (reported)October 27, 2014
Actual (reported)April 2015
Actual (reported)April 2015
Actual (reported)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
Every patient that are at least 18 years old with a planned pelvic magnetic resonance imagery and an adnexectomy within the institution.
Women with adnexal masses, with a planned pelvic magnetic resonance imagery and a planned adnexectomy within the institution, having signed the informed consent form.
CHU Brugmann
Brussels, 1020, Belgium
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.
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.
Carine De Prez, Chef de service
CHU Brugmann
Françoise HULET, MD
CHU Brugmann
13 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2014
First Posted
October 27, 2014
Study Start
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)Last Updated
May 18, 2015
Record last verified: 2015-05
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