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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)

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ClinicalTrials.gov Identifier: NCT02836275
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Dirk Timmerman, KU Leuven

Brief 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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
Experimental: Perfusion and diffusion-weighted MRI Other: Diffusion/Perfusion-weighted Magnetic Resonance Imaging



Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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.

  3. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any adult woman with an adnexal mass unclassified by gynecological ultrasound using the IOTA Simple Rules.
  • Patient planned for surgery.

Exclusion Criteria:

  • Any lesion with conclusive result on gynecological ultrasound using the IOTA Simple Rules.
  • Cysts that are deemed to be clearly physiological and less than 3 cm in maximum diameter are not eligible for inclusion.
  • No surgery performed or surgery performed >120 days after ultrasound scan.
  • Denial or withdrawal of informed consent.
  • Contra-indication for MRI
  • Current pregnancy
  • Age < 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836275


Contacts
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Contact: Dirk Timmerman, MD, PhD +32 16 344201 dirk.timmerman@uzleuven.be
Contact: Vincent Vandecaveye, MD, PhD +32 16 340518 vincent.vandecaveye@uzleuven.be

Locations
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Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Vincent Vandecaveye, PhD         
Sponsors and Collaborators
KU Leuven
Investigators
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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
Publications:

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Responsible Party: Dirk Timmerman, Prof. Dr., KU Leuven
ClinicalTrials.gov Identifier: NCT02836275    
Other Study ID Numbers: IOTA-MRI s59142
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Keywords provided by Dirk Timmerman, KU Leuven:
Adnexal Diseases
Ovary
Ovarian Neoplasms
Ovarian Cysts
Ovarian Diseases
Ultrasonography
Ultrasonography, Doppler
Magnetic Resonance Imaging
Diffusion Magnetic Resonance Imaging
Diagnosis
Early Diagnosis
Early Detection of Cancer
Genital Neoplasms, Female
Genital Diseases, Female
Urogenital Neoplasms
Cysts
Endocrine System Diseases
Gonadal Disorders
Neoplasms
Endocrine Gland Neoplasms
International Ovarian Tumor Analysis
Simple Rules
Preoperative Evaluation
Perfusion -and Diffusion-weighted Imaging
Adnexal Masses
Ovarian Tumors
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders