An observational study in Ovarian Tumor, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by University of Wisconsin, Madison · Observational
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.
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 1,340 is above the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
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All patients with an indeterminate ultrasonographically adnexal mass referred for MR imaging
Exclusion Criteria:
Scoring system used to standardize the imaging report for sonographically indeterminate adnexal masses.
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
Time frame: 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.
Time frame: 24 months
Reproducibility of the score
If ADNEXMR SCORING system improves reproducibility of MR report for characterization of adnexal masses
Time frame: 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
Time frame: 24 months
Plan to share: Yes — 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
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison