Clinical trial NCT02275273: Adnexal Masses : Correlation Between MRI (Magnetic Resonance Imagery) and Anatomopathology
Official title: Adnexal Masses : Correlation Between MRI (Magnetic Resonance Imagery) and Anatomopathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adnexal Masses
Keywords: Adnexal Masses
Magnetic Resonance Imaging
Anatomopathology
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: RECIST criteria
timeFrame: at MRI diagnosis
measure: Percentage of epithelial and conjunctive zones in the adnexal mass obtained by surgery
timeFrame: 24h after MRI diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Carine De Prez, Chef de service
role: STUDY_DIRECTOR
affiliation: CHU Brugmann
name: Françoise HULET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.