Value of MRI in the Characterization of Ovarian Masses Unable to Classify With Ultrasound Using the International Ovarian Tumor Analysis (IOTA) Simple Rules

Summary

Gynecological ultrasound is well known as the preferred exam to assess patients with ovarian tumors. The International Ovarian Tumor Analysis (IOTA) group developed the 'Simple Rules' to classify an ovarian tumor as benign or malignant. In about 1/5 of patients the Simple Rules give an inconclusive result and therefore a suitable second line test is necessary. Recently the ADNEXMR SCORING system was developed, this is the first Magnetic Resonance Imaging (MRI) score system that focuses on ovarian tumors.

The aim of this prospective study is to evaluate the performance of pelvic MRI examination with perfusion -and diffusion- weighted sequences and the application of the ADNEXMR SCORING system in ovarian tumors that cannot be classified by the IOTA Simple Rules (regarding the prediction of malignancy). Other aims are the determination of the malignancy rate per ADNEXMR SCORING system class, the evaluation of interobserver reproducibility and the assessment of the accuracy of the specific diagnosis based on MRI images.

The study is a multicenter prospective study. In centers where perfusion -and diffusion weighted MRI imaging is not a part of clinical routine in unclassifiable ovarian masses based on ultrasound, the study is considered to be interventional. However, in other centres, depending on the local guidelines, perfusion -and diffusion weighted MRI imaging can be standard of care. In these centres, the study can be considered to be observational.

The IOTA-MRI project is linked to the IOTA study. In this multicenter study different diagnostic ultrasound algorithms are tested prospectively in patients with an ovarian mass prior to surgery. This study allows to define a subgroup of patients in which Simple Rules are inconclusive, in other words the population eligible for inclusion in the IOTA-MRI project. We plan to include 250 patients in the IOTA-MRI study. Patients will be included consecutively, yet only after completing the informed consent. Recruitment will take 2 years of time as of the start of the individual center.

The gold standard is the histopathology diagnosis of the mass within 120 days after ultrasound evaluation. The surgical approach is chosen by the managing clinician.

Conditions

• Patients With a Sonographically Unclassifiable Adnexal Mass Using the IOTA Simple Rules

Interventions

OTHER

Diffusion/Perfusion-weighted Magnetic Resonance Imaging

Sponsors & Collaborators

• KU Leuven

  lead OTHER

Principal Investigators

• Isabelle Thomassin-Naggara, MD, PhD · Department of Radiology, Hôpital Tenon, Paris, FRANCE

• Andrea Rockall, MBBS, MRCP, FRCR · Imperial College London, London, UNITED KINGDOM

• Tom Bourne, MD, PhD · Queen Charlotte's & Chelsea Hospital, Imperial College London, London, UNITED KINGDOM

• Ben Van Calster, MSc, PhD · Department Development & Regeneration, KU Leuven, Leuven, BELGIUM

• Ignace Vergote, MD, PhD · Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, BELGIUM

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-31

Primary Completion

2020-12-31

Completion

2020-12-31

Countries

• Belgium

Study Locations