Clinical trial NCT01738789: EURAD-MR Classification : European Multicenter Study
Official title: European Multicenter Validation of an ADNEXMR SCORING System for Characterizing Adnexal Masses: "EURAD-MR Classification"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Tumor
Keywords: Adnexal masses
Magnetic resonance imaging
Ovarian tumor
Lead sponsor: Société d'Imagerie de la Femme
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 1340
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 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).

Primary outcomes:
measure: External validation of Adnex MR scoring system
timeFrame: 24 months
Secondary outcomes:
measure: Potential reduction of unnecessary surgery
timeFrame: 24 months
measure: Reproducibility of the score
timeFrame: 24 months
measure: Comparison between a blinded and an unblinded radiologist regarding sonographic data
timeFrame: 24 months
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: University Institute of Radiology
city: Zagreb
country: Croatia
facility: University Hospital Dubrav
city: Lille
country: France
facility: Centre Oscar Lambret
city: Marseille
country: France
facility: Hopital de la Timone
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: Hopital de Lapeyronie
city: Paris
country: France
facility: Tenon Hospital
city: Paris
country: France
facility: Centre imagerie Pyramides
city: Paris
country: France
facility: Hopital Européen Georges Pompidou
city: Paris
country: France
facility: Hopital Lariboisière
city: Paris
country: France
facility: Hôpital de la Pitié-Salpétrière
city: Paris
country: France
facility: Institut Curie - Huguenin
city: Valenciennes
country: France
facility: Hopital de Valenciennes
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Roma
country: Italy
facility: Umberto I hospital Sapienza
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Lisboa
country: Portugal
facility: Instituto Portuges de Oncologia de Lisboa Francisco Gentil
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodine
city: Baden
country: Switzerland
facility: University Hodpital Dubrav
city: Cambridge
country: United Kingdom
facility: Addenbrokes hospital
city: London
country: United Kingdom
facility: Barts Health NHS trust
city: London
country: United Kingdom
facility: Imperial College Healthcare
city: London
country: United Kingdom
facility: University College London
city: Stockport
country: United Kingdom
facility: Steeping Hill hospital
Study officials:
affiliation: Assistance Publique des Hopitaux de Paris, Université Pierre et Marie Curie
name: Isabelle Thomassin-Naggara, MD, PhD
role: STUDY_CHAIR
affiliation: Imperial College of London
name: Andrea Rockall, MD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marc Bazot, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wengert GJ, Dabi Y, Kermarrec E, Jalaguier-Coudray A, Poncelet E, Porcher R, Thomassin-Naggara I, Rockall AG; EURAD Study Group. O-RADS MRI Classification of Indeterminate Adnexal Lesions: Time-Intensity Curve Analysis Is Better Than Visual Assessment. Radiology. 2022 Jun;303(3):566-575. doi: 10.1148/radiol.210342. Epub 2022 Mar 1.