Trials / Completed
CompletedNCT02962596
EURAD MRI Classification of US Indeterminate Adnexa Lesions
European Multicenter Validation of an ADNEXMR SCORING System for Characterizing Adnexal Masses: EURAD-MR Classification
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,340 (actual)
- Sponsor
- University of Wisconsin, Madison · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | ADNEXMR SCORING system | Scoring system used to standardize the imaging report for sonographically indeterminate adnexal masses. |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2016-10-14
- Completion
- 2018-08-15
- First posted
- 2016-11-11
- Last updated
- 2020-03-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02962596. Inclusion in this directory is not an endorsement.