EURAD MRI Classification of US Indeterminate Adnexa Lesions

NCT02962596 | Completed

• 3 other identifiers: 2014-0112A539320SMPH/RADIOLOGY/RADIOLOGY
• Study Type: observational
• Target: 1,340
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  24 months

• Reproducibility of the score

  24 months

• Comparison between a blinded and an unblinded radiologist regarding sonographic data

  24 months

Interventions

ADNEXMR SCORING system OTHER

Scoring system used to standardize the imaging report for sonographically indeterminate adnexal masses.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients under 18 years of age

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related 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 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.

  PMID: 31977064 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• 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 of London

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 11, 2016
• Study Start: February 1, 2014
• Primary Completion: October 14, 2016
• Study Completion: August 15, 2018
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)