EURAD-MR Classification : European Multicenter Study
Conditions
Ovarian Tumor
Conditions: official terms
Ovarian Neoplasms
Conditions: Keywords
Adnexal masses, Magnetic resonance imaging, Ovarian tumor
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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).
Locations
University Institute of Radiology
Salzburg, Austria
Status: Recruiting
Contact: Rosemarie Forstner - R.Forstner@salk.at
CHU de Liège
Liège, Belgium
Status: Withdrawn
University Hospital Dubrav
Zagreb, Croatia
Status: Not yet recruiting
Contact: I Giordana - gordana.augustan@gmail.com
Centre Oscar Lambret
Lille, France
Status: Recruiting
Contact: Sophie Taieb, MD - S-Taieb@o-lambret.fr
Hopital de la Timone
Marseille, France
Status: Recruiting
Contact: Valerie Juhan, MD - Valerie.JUHAN@ap-hm.fr
Institut Paoli Calmettes
Marseille, France
Status: Recruiting
Contact: Aurélie Jalaguier, MD - aureliejalaguier@yahoo.fr
Hopital de Lapeyronie
Montpellier, France
Status: Recruiting
Contact: Patrice Taourel, MD - patricetaourel@wanadoo.fr
Centre imagerie Pyramides
Paris, France
Status: Recruiting
Contact: Nicolas Perrot, MD - vitenson@wanadoo.fr
Hopital Européen Georges Pompidou
Paris, France
Status: Recruiting
Contact: Laure Fournier, MD, PhD - laure.fournier@gmail.com
Hopital Lariboisière
Paris, France
Status: Recruiting
Contact: Sandra Bendavid, MD - sandrabendavid@free.fr
Hôpital de la Pitié-Salpétrière
Paris, France
Status: Recruiting
Contact: Olivier Lucidarme, MD, PhD - olivier.lucidarme@gmail.com
Institut Curie - Huguenin
Paris, France
Status: Recruiting
Contact: Helene Berment, MD - helene.berment@curie.net
Tenon Hospital
Paris, France
Status: Recruiting
Contact: Isabelle Thomassin-Naggara, MD, PhD - 0663067321 - isabellethomassin@tnn.aphp.fr
Hopital de Valenciennes
Valenciennes, France
Status: Recruiting
Contact: Edouard Poncelet, MD - poncelet.edouard@gmail.com
Institut Gustave Roussy
Villejuif, France
Status: Recruiting
Contact: Corinne Balleyguier, MD - balleyguier@igr.fr
John Paul Catholic University
Campobasso, Italy
Status: Withdrawn
Umberto I hospital Sapienza
Roma, Italy
Status: Recruiting
Contact: G Masseli - g.masselli@policlinicoumberto1.it
Instituto di Radiologia
Verona, Italy
Status: Withdrawn
Hospital da Luz
Lisboa, Portugal
Status: Recruiting
Contact: Aldagisa Guerra - gisaguerra@gmail.com
Instituto Portuges de Oncologia de Lisboa Francisco Gentil
Lisboa, Portugal
Status: Recruiting
Contact: Teresa Margarida Cunha - tmargarida@gmail.com
Clinical Center of Vojvodine
Novi Sad, Serbia
Status: Recruiting
Contact: Sanja Stojanovic - tupsons@gmail.com
University Hodpital Dubrav
Baden, Switzerland
Status: Not yet recruiting
Contact: Rahel Kubik - Rahel.Kubik@ksb.ch
Addenbrokes hospital
Cambridge, United Kingdom
Status: Recruiting
Contact: Suzan Freeman, MD
Barts Health NHS trust
London, United Kingdom
Status: Recruiting
Contact: Anju Sahdev - Anju.Sahdev@bartshealth.nhs.uk
Imperial College Healthcare
London, United Kingdom
Status: Recruiting
Contact: Andrea Rockall, MD - a.rockall@imperial.ac.uk
University College London
London, United Kingdom
Status: Recruiting
Contact: M Hall-Craggs, MD
Steeping Hill hospital
Stockport, United Kingdom
Status: Recruiting
Contact: Maryna Lewinski - Maryna.Lewinski@stockport.nhs.uk
Start Date
March 2013
Completion Date
September 2017
Sponsors
Société d'Imagerie de la Femme
Source
Société d'Imagerie de la Femme
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page