EURAD-MR Classification : European Multicenter Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Société d'Imagerie de la Femme
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: October 25, 2013
Last verified: October 2013
  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 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


Estimated Enrollment: 1340
Study Start Date: March 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2014 (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

Contacts
Contact: Isabelle Thomassin-Naggara, MD, PhD 0156016453 isabelle.thomassin@tnn.aphp.fr

Locations
Austria
University Institute of Radiology Recruiting
Salzburg, Austria
Contact: Rosemarie Forstner       R.Forstner@salk.at   
Principal Investigator: Rosemarie Forstner         
Belgium
CHU de Liège Not yet recruiting
Liège, Belgium
Contact: Alain Thille, MD       alain@thille.be   
Principal Investigator: Alain Thille         
Croatia
University Hospital Dubrav Not yet recruiting
Zagreb, Croatia
Contact: I Giordana       gordana.augustan@gmail.com   
Principal Investigator: I Giordana         
France
Centre Oscar Lambret Recruiting
Lille, France
Contact: Sophie Taieb, MD       S-Taieb@o-lambret.fr   
Principal Investigator: Sophie Taeib, MD         
Sub-Investigator: Luc Ceugnart, MD         
Sub-Investigator: Corinne Jumelle, MD         
Institut Paoli Calmettes Recruiting
Marseille, France
Contact: Aurélie Jalaguier, MD       aureliejalaguier@yahoo.fr   
Principal Investigator: Aurélie Jalaguier, MD         
Hopital de la Timone Recruiting
Marseille, France
Contact: Valerie Juhan, MD       Valerie.JUHAN@ap-hm.fr   
Principal Investigator: Valerie Juhan, MD         
Sub-Investigator: Pascale Siles, MD         
Hopital de Lapeyronie Recruiting
Montpellier, France
Contact: Patrice Taourel, MD       patricetaourel@wanadoo.fr   
Principal Investigator: Patrice Taourel, MD         
Principal Investigator: Ingrid Millet, MD         
Tenon Hospital Recruiting
Paris, France, 75020
Contact: Isabelle Thomassin-Naggara, MD, PhD    0663067321    isabellethomassin@tnn.aphp.fr   
Principal Investigator: Isabelle Thomassin-Naggara, MD, PhD         
Sub-Investigator: Marc Bazot, MD         
Hopital Lariboisière Recruiting
Paris, France
Contact: Sandra Bendavid, MD       sandrabendavid@free.fr   
Principal Investigator: Sandra Bendavid, MD         
Sub-Investigator: Delphine Sebbag, MD         
Institut Curie - Huguenin Recruiting
Paris, France
Contact: Helene Berment, MD       helene.berment@curie.net   
Principal Investigator: Helene Berment, MD         
Principal Investigator: Caroline Malhaire, MD         
Hôpital de la Pitié-Salpétrière Recruiting
Paris, France
Contact: Olivier Lucidarme, MD, PhD       olivier.lucidarme@gmail.com   
Principal Investigator: Olivier Lucidarme, MD, PhD         
Sub-Investigator: Yasmina Badachi, MD         
Hopital Européen Georges Pompidou Recruiting
Paris, France
Contact: Laure Fournier, MD, PhD       laure.fournier@gmail.com   
Principal Investigator: Laure Fournier, MD, PhD         
Sub-Investigator: Foucauld Chamming's, MD         
Centre imagerie Pyramides Recruiting
Paris, France
Contact: Nicolas Perrot, MD       vitenson@wanadoo.fr   
Principal Investigator: Nicolas Perrot, MD         
Sub-Investigator: Isabelle Frey, MD         
Sub-Investigator: Carine Ribeiro, MD         
Hopital de Valenciennes Recruiting
Valenciennes, France
Contact: Edouard Poncelet, MD       poncelet.edouard@gmail.com   
Principal Investigator: Edouard Poncelet, MD         
Institut Gustave Roussy Recruiting
Villejuif, France
Contact: Corinne Balleyguier, MD       balleyguier@igr.fr   
Principal Investigator: Corinne Balleyguier, MD         
Sub-Investigator: Sandra Canale, MD         
Italy
John Paul Catholic University Not yet recruiting
Campobasso, Italy
Contact: G Reistano       grestaino@rm.unicatt.it   
Principal Investigator: G Reistano         
Umberto I hospital Sapienza Not yet recruiting
Roma, Italy
Contact: G Masseli       g.masselli@policlinicoumberto1.it   
Principal Investigator: G Masseli         
Instituto di Radiologia Not yet recruiting
Verona, Italy
Contact: Roberto Pozzi-Mucelli       roberto.pozzimucelli@uniivr.it   
Principal Investigator: Roberto Pozzi-Mucelli         
Sub-Investigator: Riccardo Manfredi         
Portugal
Instituto Portuges de Oncologia de Lisboa Francisco Gentil Recruiting
Lisboa, Portugal
Contact: Teresa Margarida Cunha       tmargarida@gmail.com   
Principal Investigator: Teresa Margarida Cunha         
Sub-Investigator: C Campos         
Hospital da Luz Recruiting
Lisboa, Portugal
Contact: Aldagisa Guerra       gisaguerra@gmail.com   
Principal Investigator: Gisa Guerra         
Serbia
Clinical Center of Vojvodine Not yet recruiting
Novi Sad, Serbia
Contact: Sanja Stojanovic       tupsons@gmail.com   
Principal Investigator: Sanja Stojanovic         
Switzerland
University Hodpital Dubrav Not yet recruiting
Baden, Switzerland
Contact: Rahel Kubik       Rahel.Kubik@ksb.ch   
Principal Investigator: Rahel Kubik         
Clinique des grangettes Not yet recruiting
Geneve, Switzerland
Contact: Karen Kinkel       karen.kinkel-trugli@wanadoo.fr   
Principal Investigator: Karen Kinkel, MD, PhD         
United Kingdom
Addenbrokes hospital Not yet recruiting
Cambridge, United Kingdom
Contact: Suzan Freeman, MD         
Principal Investigator: Susan Freeman, MD         
Imperial College Healthcare Not yet recruiting
London, United Kingdom
Contact: Andrea Rockall, MD       a.rockall@imperial.ac.uk   
Principal Investigator: Andrea Rockall, MD         
Sub-Investigator: Nishat Bharwani, MD         
University College London Not yet recruiting
London, United Kingdom
Contact: M Hall-Craggs, MD         
Principal Investigator: M Hall-Craggs         
Barts Health NHS trust Not yet recruiting
London, United Kingdom
Contact: Anju Sahdev       Anju.Sahdev@bartshealth.nhs.uk   
Principal Investigator: Anju Sahdev         
Steeping Hill hospital Not yet recruiting
Stockport, United Kingdom
Contact: Maryna Lewinski       Maryna.Lewinski@stockport.nhs.uk   
Principal Investigator: Maryna Lewinski         
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

No publications provided

Responsible Party: Isabelle Thomassin-Naggara, Associate 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: October 25, 2013
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
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 26, 2014