Skip to main content
OpenTrials
Completed

NCT Number: NCT02962596

EURAD MRI Classification of US Indeterminate Adnexa Lesions

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients under 18 years of age

Treatment and study plan

ADNEXMR SCORING system

Other

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

Primary outcomes

  1. Reproducibility of the ADNEX MR scoring system between centers

    Time frame: 24 months

    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

Secondary outcomes

  1. 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.

    Time frame: 24 months

    The potential impact of applying the score to the therapeutic strategy, in particular to measure the possible reduction in unnecessary surgery in benign cases.

  2. Reproducibility of the score

    Time frame: 24 months

    If ADNEXMR SCORING system improves reproducibility of MR report for characterization of adnexal masses

  3. Comparison between a blinded and an unblinded radiologist regarding sonographic data

    Time frame: 24 months

    If ADNEXMR SCORING system is as accurate if the radiologist is blinded from any clinical and ultrasonographic data

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Nov 11, 2016
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.