EURAD-MR Classification : European Multicenter Study (EURAD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Isabelle Thomassin-Naggara, Société d'Imagerie de la Femme
ClinicalTrials.gov Identifier:
NCT01738789
First received: November 28, 2012
Last updated: April 19, 2016
Last verified: April 2016
  Purpose

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.


Condition
Ovarian Tumor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Multicenter Validation of an ADNEXMR SCORING System for Characterizing Adnexal Masses: "EURAD-MR Classification"

Resource links provided by NLM:


Further study details as provided by Société d'Imagerie de la Femme:

Primary Outcome Measures:
  • External validation of Adnex MR scoring system [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Potential reduction of unnecessary surgery [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The potential impact of applying the score to the therapeutic strategy, in particular to measure the possible reduction in unnecessary surgery in benign cases

  • Reproducibility of the score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    If ADNEXMR SCORING system improves reproducibility of MR report for characterization of adnexal masses

  • Comparison between a blinded and an unblinded radiologist regarding sonographic data [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    If ADNEXMR SCORING system is as accurate if the radiologist is blinded from any clinical and ultrasonographic data


Enrollment: 1340
Study Start Date: March 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738789

Locations
Austria
University Institute of Radiology
Salzburg, Austria
Croatia
University Hospital Dubrav
Zagreb, Croatia
France
Centre Oscar Lambret
Lille, France
Hopital de la Timone
Marseille, France
Institut Paoli Calmettes
Marseille, France
Hopital de Lapeyronie
Montpellier, France
Tenon Hospital
Paris, France, 75020
Centre imagerie Pyramides
Paris, France
Institut Curie - Huguenin
Paris, France
Hopital Lariboisière
Paris, France
Hôpital de la Pitié-Salpétrière
Paris, France
Hopital Européen Georges Pompidou
Paris, France
Hopital de Valenciennes
Valenciennes, France
Institut Gustave Roussy
Villejuif, France
Italy
Umberto I hospital Sapienza
Roma, Italy
Portugal
Hospital da Luz
Lisboa, Portugal
Instituto Portuges de Oncologia de Lisboa Francisco Gentil
Lisboa, Portugal
Serbia
Clinical Center of Vojvodine
Novi Sad, Serbia
Switzerland
University Hodpital Dubrav
Baden, Switzerland
United Kingdom
Addenbrokes hospital
Cambridge, United Kingdom
Barts Health NHS trust
London, United Kingdom
Imperial College Healthcare
London, United Kingdom
University College London
London, United Kingdom
Steeping Hill hospital
Stockport, United Kingdom
Sponsors and Collaborators
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
Study Director: Andrea Rockall, MD Imperial College of London
Principal Investigator: Marc Bazot, MD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Isabelle Thomassin-Naggara, Full Professor, Société d'Imagerie de la Femme
ClinicalTrials.gov Identifier: NCT01738789     History of Changes
Other Study ID Numbers: SIFEM-2013-1 
Study First Received: November 28, 2012
Last Updated: April 19, 2016
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Société d'Imagerie de la Femme:
Adnexal masses
Magnetic resonance imaging
Ovarian tumor

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on May 05, 2016