EURAD-MR Classification : European Multicenter Study (EURAD)

July 25, 2017 updated by: Isabelle Thomassin-Naggara, Société d'Imagerie de la Femme

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

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

All patients with an indeterminate ultrasonographically adnexal mass referred for MR imaging will be consecutively included in each center.

Inclusion Criteria

  • Patient ≥ 18 years old
  • With indeterminate ultrasonographic adnexal mass
  • Informed consent

Non inclusion Criteria

  • Pregnant women
  • Pacemaker, ferromagnetic materials, or foreign body at risk of mobilization
  • Intolerance to iodinated or gadolinium contrast agents, or severe renal insufficiency (GFR <30 ml/min/1.73m²).

Objectives • Primary objective: 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 objectives and endpoints: Evaluate

  1. The potential impact of applying the score to the therapeutic strategy, in particular to measure the possible reduction in oncologic surgery in benign cases
  2. If ADNEXMR SCORING system improves reproducibility of MR report for characterization of adnexal masses
  3. If ADNEXMR SCORING system is as accurate if the radiologist is blinded from any clinical and ultrasonographic data

Main endpoint Joint analysis of true negative and false negative rates according to ADNEXMR SCORING system as compared to the histological results (or follow-up outcome, see "reference standard", below) with an evaluation of the sensitivity and the specificity of the score

Study Type

Observational

Enrollment (Actual)

1340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
        • University Institute of Radiology
  • Croatia
      • Zagreb, Croatia
        • University Hospital Dubrav
  • France
      • Lille, France
        • Centre Oscar Lambret
      • Marseille, France
        • Institut Paoli Calmettes
      • Marseille, France
        • Hopital de la Timone
      • Montpellier, France
        • Hopital de Lapeyronie
      • Paris, France
        • Hôpital Lariboisière
      • Paris, France
        • Hôpital Européen Georges Pompidou
      • Paris, France
        • Hôpital de la Pitié-Salpêtrière
      • Paris, France, 75020
        • Tenon Hospital
      • Paris, France
        • Centre imagerie Pyramides
      • Paris, France
        • Institut Curie - Huguenin
      • Valenciennes, France
        • Hopital de Valenciennes
      • Villejuif, France
        • Institut Gustave Roussy
  • Italy
      • Roma, Italy
        • Umberto I hospital Sapienza
  • Portugal
      • Lisboa, Portugal
        • Hospital da Luz
      • Lisboa, Portugal
        • Instituto Portuges de Oncologia de Lisboa Francisco Gentil
  • Serbia
      • Novi Sad, Serbia
        • Clinical Center of Vojvodine
  • Switzerland
      • Baden, Switzerland
        • University Hodpital Dubrav
  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrokes Hospital
      • London, United Kingdom
        • University College London
      • London, United Kingdom
        • Barts Health NHS Trust
      • London, United Kingdom
        • Imperial College Healthcare
      • Stockport, United Kingdom
        • Steeping Hill hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All patients with a sonographically indeterminate adnexal mass referred for MR imaging will be consecutively included in each center

Description

Inclusion Criteria

  • Patient ≥ 18 years old
  • With sonographically indeterminate adnexal mass
  • Informed consent

Exclusion Criteria

  • Pregnant women (relative contra indication for gadolinium injection)
  • Pacemaker, ferromagnetic materials, or foreign body at risk of mobilization or any other contra-indication to MR imaging.
  • Intolerance to iodinated or gadolinium contrast agents, or severe renal insufficiency (GFR <30 ml/min/1.73m²).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
External validation of Adnex MR scoring system
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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potential reduction of unnecessary surgery
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
24 months
Reproducibility of the score
Time Frame: 24 months
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
Time Frame: 24 months
If ADNEXMR SCORING system is as accurate if the radiologist is blinded from any clinical and ultrasonographic data
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société d'Imagerie de la Femme

Investigators

  • Study Chair: Isabelle Thomassin-Naggara, MD, PhD, Assistance Publique des Hopitaux de Paris, Université Pierre et Marie Curie
  • Principal Investigator: Marc Bazot, MD, Assistance Publique - Hopitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2018

Study Completion (ANTICIPATED)

March 1, 2018

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

November 28, 2012

First Posted (ESTIMATE)

November 30, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIFEM-2013-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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