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EURAD-MR Classification : European Multicenter Study

NCT01738789 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1340

Last updated 2017-07-26

No results posted yet for this study

Summary

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 patient management. Recently, our center developed the first MR scoring system named ADNEXMR SCORING system in a retrospective study which is accurate and reproducible (1). Our objectives 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 consecutively included in each center. Then, patients will undergo a routine pelvic MR imaging. Prospectively, one senior and one junior radiologists independently analyze the different MR criteria to characterize adnexal masses. The MR report will be issued as standard and the patient will be managed accordingly. Then, the reader will classify the mass using ADNEXMR SCORING system. The classification will be compared to the reference standard as defined below. The reproducibility of the classification will be tested between the junior and the senior radiologist. After anonymisation, images will be analyzed by another senior radiologist of another center blinded from any clinical or ultrasonographical data and correlated with the reference standard.

Reference standard: Reference standard will be surgical procedure with histology or standard clinical follow-up depending on most appropriate routine practice.

Sample size: The sample size was computed to ensure a power of at least 90% (with a two-sided type I error rate of 5%) to conclude that SCORE 2 and 3 and SCORE 4 and 5 would have a different PPV. It would thus be necessary to have at least 569 patients classified as SCORE 2, 259 as SCORE 3, 52 as SCORE 4 and 51 as SCORE 5 (18). Given the prevalences, and assuming 6% of patients would be classified, as SCORE 1 and 10% would be lost to follow-up, 1340 patients will be included in this study to insure a probability of at least 95% to obtain the aforementioned number of patients in each score category. The inclusion period will last 18 months (extension for a period of 12 months) and monitoring will continue for 2 years.

Thomassin Naggara I., et al. Development and preliminary validation of an MRI Scoring system for Adnexal Masses. Radiology 2013, May;267(2):432-43.

Conditions

  • Ovarian Tumor

Sponsors & Collaborators

  • Société d'Imagerie de la Femme

    lead OTHER

Principal Investigators

  • Isabelle Thomassin-Naggara, MD, PhD · Assistance Publique des Hopitaux de Paris, Université Pierre et Marie Curie

  • Andrea Rockall, MD · Imperial College of London

  • Marc Bazot, MD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Austria
  • Croatia
  • France
  • Italy
  • Portugal
  • Serbia
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01738789 on ClinicalTrials.gov