Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| A539320 | Other Identifier | UW Madison | |
| SMPH/RADIOLOGY/RADIOLOGY | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADNEXMR SCORING system | Other | Scoring system used to standardize the imaging report for sonographically indeterminate adnexal masses. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All patients with an indeterminate ultrasonographically adnexal mass referred for MR imaging
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Sadowski, MD | University of Wisconsin, Madison | Principal Investigator |
| Isabelle Thomassin-Naggara, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Andrea Rockall, MD | Imperial College London | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31977064 | Result | 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. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |