EURAD MRI Classification of US Indeterminate Adnexa Lesions

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

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Tumor
• Intervention / Treatment: Other: ADNEXMR SCORING system

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 Type: Observational
• Enrollment (Actual): 1340

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All patients with an indeterminate ultrasonographically adnexal mass referred for MR imaging

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients under 18 years of age

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility of the score	If ADNEXMR SCORING system improves reproducibility of MR report for characterization of adnexal masses	24 months
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
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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Elizabeth Sadowski, MD, University of Wisconsin, Madison; Study Chair: Isabelle Thomassin-Naggara, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): October 14, 2016
• Study Completion (Actual): August 15, 2018

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms
• Other Study ID Numbers: 2014-0112 (Other Identifier: M D Anderson Cancer Center); SMPH/RADIOLOGY/RADIOLOGY (Other Identifier: UW Madison); A539320 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Images and associated data will be labeled with a unique study number that identifies the research site and the patient number (e.g. UWisc001). The link to identifiable information will remain at the University of Wisconsin