Value of MRI in the Characterization of Ovarian Masses Unable to Classify With Ultrasound Using the International Ovarian Tumor Analysis (IOTA) Simple Rules (IOTA-MRI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02836275|
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : April 14, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Patients With a Sonographically Unclassifiable Adnexal Mass Using the IOTA Simple Rules||Other: Diffusion/Perfusion-weighted Magnetic Resonance Imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Characterization of Ovarian Masses Unable to Classify With Ultrasound Using the International Ovarian Tumor Analysis (IOTA) Simple Rules: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging|
|Actual Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
|Experimental: Perfusion and diffusion-weighted MRI||
Other: Diffusion/Perfusion-weighted Magnetic Resonance Imaging
- The sensitivity and specificity of the ADNEXMR SCORING system in classifying adnexal masses as malignant or benign using MRI with diffusion- and perfusion-weighted sequences in masses unclassified by the IOTA Simple Rules. [ Time Frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 120 days after ultrasound examination. ]
- Proportion of malignant masses per level of the ADNEXMR SCORING system. [ Time Frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 120 days after ultrasound examination. ]
- Interobserver reproducibility of ADNEXMR SCORING system using MRI with diffusion- and perfusion-weighted sequences by comparing lesion characterization (interpretation) and region of interest delineation on the perfusion curve. [ Time Frame: During estimated recruitment period of 2 years. ]This will take place later using stored images.
- Accuracy of the suggested specific diagnosis made on the basis of the MRI images. [ Time Frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 120 days after ultrasound examination. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836275
|Contact: Dirk Timmerman, MD, PhD||+32 16 email@example.com|
|Contact: Vincent Vandecaveye, MD, PhD||+32 16 firstname.lastname@example.org|
|University Hospitals Leuven||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Vincent Vandecaveye, PhD|
|Study Chair:||Isabelle Thomassin-Naggara, MD, PhD||Department of Radiology, Hôpital Tenon, Paris, FRANCE|
|Study Chair:||Andrea Rockall, MBBS, MRCP, FRCR||Imperial College London, London, UNITED KINGDOM|
|Study Chair:||Tom Bourne, MD, PhD||Queen Charlotte's & Chelsea Hospital, Imperial College London, London, UNITED KINGDOM|
|Study Chair:||Ben Van Calster, MSc, PhD||Department Development & Regeneration, KU Leuven, Leuven, BELGIUM|
|Study Chair:||Ignace Vergote, MD, PhD||Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, BELGIUM|