Clinical trial NCT02962596: EURAD MRI Classification of US Indeterminate Adnexa Lesions
Official title: European Multicenter Validation of an ADNEXMR SCORING System for Characterizing Adnexal Masses: EURAD-MR Classification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Tumor
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 1340
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with an indeterminate ultrasonographically adnexal mass referred for MR imaging

Brief summary: This research is targeting patients with sonographically indeterminate adnexal mass that are being referred for clinical MR imaging. Investigators from the UW will be contributing coded MR images and associated health information (US results, laboratory/pathology results) to the EURAD trial. In addition, outcomes data on each patient will be sent at month 24 of the research.

Detailed description: An adnexal mass is the most common indication for gynaecological surgery. Pre operative characterization is crucial and a scoring system would be useful to standardize the imaging report and thus, improve patients management. Recently, the coordinating center developed the first MR scoring system named ANDEXMR SCORING system in a retrospective study which is accurate and reproducible. The objectives of this trial are to perform an external prospective validation of this scoring system to evaluate its potential impact on therapeutic strategy and to test its reproducibility.

This is a prospective large multicenter study. All patients with a sonographically indeterminate adnexal mass referred for MR imaging will be included from each participating center. One senior and one junior radiologists independently analyze the different MR criteria to characterize adnexal masses. The reader will then classify the mass using ADNEXMR SCORING system.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* With indeterminate ultrasonographic adnexal mass

Exclusion Criteria:

* Patients under 18 years of age

Primary outcomes:
measure: Reproducibility of the ADNEX MR scoring system between centers
timeFrame: 24 months
Secondary outcomes:
measure: Differences in rate of surgery in women with adnexal lesions in those where the ADNEX MR score is used compared to when it is not used.
timeFrame: 24 months
measure: Reproducibility of the score
timeFrame: 24 months
measure: Comparison between a blinded and an unblinded radiologist regarding sonographic data
timeFrame: 24 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Elizabeth Sadowski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Isabelle Thomassin-Naggara, MD, PhD
role: STUDY_CHAIR
affiliation: Imperial College of London
name: Andrea Rockall, MD
role: STUDY_DIRECTOR
References:
citation: Thomassin-Naggara I, Poncelet E, Jalaguier-Coudray A, Guerra A, Fournier LS, Stojanovic S, Millet I, Bharwani N, Juhan V, Cunha TM, Masselli G, Balleyguier C, Malhaire C, Perrot NF, Sadowski EA, Bazot M, Taourel P, Porcher R, Darai E, Reinhold C, Rockall AG. Ovarian-Adnexal Reporting Data System Magnetic Resonance Imaging (O-RADS MRI) Score for Risk Stratification of Sonographically Indeterminate Adnexal Masses. JAMA Netw Open. 2020 Jan 3;3(1):e1919896. doi: 10.1001/jamanetworkopen.2019.19896.