EURAD-MR Classification : European Multicenter Study

Ovarian Tumor Clinical Trial

— EURAD  

Official title:

European Multicenter Validation of an ADNEXMR SCORING System for Characterizing Adnexal Masses: "EURAD-MR Classification"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01738789
• Other study ID #: SIFEM-2013-1
• Status: Active, not recruiting
• Phase: N/A
• First received: November 28, 2012
• Last updated: July 25, 2017
• Start date: March 2013
• Est. completion date: March 2018

Study information

• Verified date: July 2017
• Source: Société d'Imagerie de la Femme
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1340
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Ovarian Neoplasms
• Ovarian Tumor

Locations

Country	Name	City	State
Austria	University Institute of Radiology	Salzburg
Croatia	University Hospital Dubrav	Zagreb
France	Centre Oscar Lambret	Lille
France	Hopital de la Timone	Marseille
France	Institut Paoli Calmettes	Marseille
France	Hopital de Lapeyronie	Montpellier
France	Centre imagerie Pyramides	Paris
France	Hôpital de la Pitié-Salpétrière	Paris
France	Hopital Européen Georges Pompidou	Paris
France	Hopital Lariboisière	Paris
France	Institut Curie - Huguenin	Paris
France	Tenon Hospital	Paris
France	Hopital de Valenciennes	Valenciennes
France	Institut Gustave Roussy	Villejuif
Italy	Umberto I hospital Sapienza	Roma
Portugal	Hospital da Luz	Lisboa
Portugal	Instituto Portuges de Oncologia de Lisboa Francisco Gentil	Lisboa
Serbia	Clinical Center of Vojvodine	Novi Sad
Switzerland	University Hodpital Dubrav	Baden
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

Sponsors (1)

Lead Sponsor	Collaborator
Société d'Imagerie de la Femme

Countries where clinical trial is conducted

Austria,  Croatia,  France,  Italy,  Portugal,  Serbia,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	External validation of Adnex MR scoring system	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	24 months
Secondary	Potential reduction of unnecessary surgery	The potential impact of applying the score to the therapeutic strategy, in particular to measure the possible reduction in unnecessary surgery in benign cases	24 months
Secondary	Reproducibility of the score	If ADNEXMR SCORING system improves reproducibility of MR report for characterization of adnexal masses	24 months
Secondary	Comparison between a blinded and an unblinded radiologist regarding sonographic data	If ADNEXMR SCORING system is as accurate if the radiologist is blinded from any clinical and ultrasonographic data	24 months