EURAD MRI Classification of US Indeterminate Adnexa Lesions

Completed

• Conditions: Ovarian Tumor

• Registration Number: NCT02962596
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2016-10-14
• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-11
• Study Completion: 2018-08-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1340

Inclusion Criteria

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

Exclusion Criteria

• Patients under 18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reproducibility of the ADNEX MR scoring system between centers	24 months	Evaluate if ADNEXMR SCORING system is relevant for reporting pelvic magnetic resonance imaging (MRI) examinations performed for characterization of sonographically indeterminate adnexal masses in an external prospective multicenter study

Secondary Outcome Measures

Name	Time	Method
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.	24 months	The potential impact of applying the score to the therapeutic strategy, in particular to measure the possible reduction in unnecessary surgery in benign cases.
Reproducibility of the score	24 months	If ADNEXMR SCORING system improves reproducibility of MR report for characterization of adnexal masses
Comparison between a blinded and an unblinded radiologist regarding sonographic data	24 months	If ADNEXMR SCORING system is as accurate if the radiologist is blinded from any clinical and ultrasonographic data

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States