Value of MRI in the Characterization of Ovarian Masses Unable to Classify With Ultrasound Using the International Ovarian Tumor Analysis (IOTA) Simple Rules
Launched by KU LEUVEN · Jul 14, 2016
Trial Information
Current as of June 15, 2025
Unknown status
Keywords
ClinConnect Summary
Ovarian cancer is a common and lethal disease for which early detection and treatment in high volume centers and by specialized clinicians is known to improve survival. Hence, accurate methods to preoperatively characterize the nature of an ovarian tumor are pivotal. The IOTA group has suggested Simple ultrasound based rules that can be used to classify adnexal masses 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. The benefit of using MRI in sonographically indeterminate masses has been ev...
Gender
FEMALE
Eligibility 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
About Ku Leuven
KU Leuven, a prestigious research university located in Belgium, is renowned for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, KU Leuven integrates cutting-edge research with clinical practice, facilitating the development of new therapeutic strategies and medical technologies. The institution's robust infrastructure and expertise in various fields, including biotechnology, pharmacology, and public health, position it as a leader in conducting high-quality clinical research that adheres to rigorous ethical standards and regulatory requirements. Through its clinical trials, KU Leuven aims to contribute significantly to the global biomedical landscape and enhance health outcomes for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Leuven, , Belgium
Patients applied
Trial Officials
Isabelle Thomassin-Naggara, MD, PhD
Study Chair
Department of Radiology, Hôpital Tenon, Paris, FRANCE
Andrea Rockall, MBBS, MRCP, FRCR
Study Chair
Imperial College London, London, UNITED KINGDOM
Tom Bourne, MD, PhD
Study Chair
Queen Charlotte's & Chelsea Hospital, Imperial College London, London, UNITED KINGDOM
Ben Van Calster, MSc, PhD
Study Chair
Department Development & Regeneration, KU Leuven, Leuven, BELGIUM
Ignace Vergote, MD, PhD
Study Chair
Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, BELGIUM
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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