EURAD-MR Classification : European Multicenter Study

NCT01738789 | Unknown

• 1 other identifier: SIFEM-2013-1
• Study Type: observational
• Target: 1,340
• Locations: 8 countries
• Sites: 24

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.

Conditions

Ovarian Tumor

Keywords

Adnexal masses; Magnetic resonance imaging; Ovarian tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Potential reduction of unnecessary surgery

  24 months

• Reproducibility of the score

  24 months

• Comparison between a blinded and an unblinded radiologist regarding sonographic data

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patient ≥ 18 years old
• With sonographically indeterminate adnexal mass
• Informed consent

You may not qualify if:

• 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).

Sponsors & Collaborators

• Société d'Imagerie de la Femme: lead

Study Sites (24)

University Institute of Radiology

Salzburg, Austria

Location

University Hospital Dubrav

Zagreb, Croatia

Location

Centre Oscar Lambret

Lille, France

Location

Hopital de la Timone

Marseille, France

Location

Institut Paoli Calmettes

Marseille, France

Location

Hopital de Lapeyronie

Montpellier, France

Location

Tenon Hospital

Paris, 75020, France

Location

Centre imagerie Pyramides

Paris, France

Location

Hopital Européen Georges Pompidou

Paris, France

Location

Hopital Lariboisière

Paris, France

Location

Hôpital de la Pitié-Salpétrière

Paris, France

Location

Institut Curie - Huguenin

Paris, France

Location

Hopital de Valenciennes

Valenciennes, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Umberto I hospital Sapienza

Roma, Italy

Location

Hospital da Luz

Lisbon, Portugal

Location

Instituto Portuges de Oncologia de Lisboa Francisco Gentil

Lisbon, Portugal

Location

Clinical Center of Vojvodine

Novi Sad, Serbia

Location

University Hodpital Dubrav

Baden, Switzerland

Location

Addenbrokes hospital

Cambridge, United Kingdom

Location

Barts Health NHS trust

London, United Kingdom

Location

Imperial College Healthcare

London, United Kingdom

Location

University College London

London, United Kingdom

Location

Steeping Hill hospital

Stockport, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35230183 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Isabelle Thomassin-Naggara, MD, PhD

  Assistance Publique des Hopitaux de Paris, Université Pierre et Marie Curie

  STUDY CHAIR

• Andrea Rockall, MD

  Imperial College of London

  STUDY DIRECTOR

• Marc Bazot, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: November 30, 2012
• Study Start: March 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

IT (1); CR (1); AU (1); GB (5); CH (1); PT (2); FR (12); SE (1)