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EURAD-MR Classification : European Multicenter Study (EURAD)

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ClinicalTrials.gov Identifier: NCT01738789
Recruitment Status : Unknown
Verified July 2017 by Isabelle Thomassin-Naggara, Société d'Imagerie de la Femme.
Recruitment status was:  Active, not recruiting
First Posted : November 30, 2012
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Isabelle Thomassin-Naggara, Société d'Imagerie de la Femme

Brief 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.


Condition or disease
Ovarian Tumor

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

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Study Type : Observational
Actual Enrollment : 1340 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Multicenter Validation of an ADNEXMR SCORING System for Characterizing Adnexal Masses: "EURAD-MR Classification"
Study Start Date : March 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738789


Locations
Show Show 24 study locations
Sponsors and Collaborators
Société d'Imagerie de la Femme
Investigators
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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

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Responsible Party: Isabelle Thomassin-Naggara, Full Professor, Société d'Imagerie de la Femme
ClinicalTrials.gov Identifier: NCT01738789    
Other Study ID Numbers: SIFEM-2013-1
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Keywords provided by Isabelle Thomassin-Naggara, Société d'Imagerie de la Femme:
Adnexal masses
Magnetic resonance imaging
Ovarian tumor
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders