EURAD MRI Classification of US Indeterminate Adnexa Lesions

Ovarian Tumor Clinical Trial

Official title:

European Multicenter Validation of an ADNEXMR SCORING System for Characterizing Adnexal Masses: EURAD-MR Classification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962596
• Other study ID #: 2014-0112
• Secondary ID: A539320SMPH/RADI
• Status: Completed
• Start date: February 2014
• Est. completion date: August 15, 2018

Study information

• Verified date: March 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1340
• Est. completion date: August 15, 2018
• Est. primary completion date: October 14, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 18 years of age or older

• With indeterminate ultrasonographic adnexal mass

Exclusion Criteria:

• Patients under 18 years of age

Related Conditions & MeSH terms

• Ovarian Neoplasms
• Ovarian Tumor

Intervention

Other:
• ADNEXMR SCORING system
Scoring system used to standardize the imaging report for sonographically indeterminate adnexal masses.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

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