Characterization of Ovarian Masses Unable to Classify With Gynecological Ultrasonography: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging

Recruiting

• Conditions: Undetermined Ovarian Mass

• Registration Number: NCT02425540
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The aim of the study is to prospectively evaluate the value of pelvic MRI including diffusion- and perfusion-weighted sequences in the selected group of patients that have an undetermined ovarian mass at ultrasound.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-14
• Study Start: 2015-03
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15
• Primary Completion: 2025-02
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

*Any woman with an adnexal mass undetermined by gynecological ultrasound

Exclusion Criteria

• Any lesion with definite diagnosis by gynecological ultrasound
• Denial or withdrawal of oral informed consent.
• Contra-indication for MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of MRI findings with histopathology or 2-years follow-up	03/2015 to 03/2017 (up to 2 years)

Trial Locations

Locations (1)

University Hospitals UZ Leuven, Gasthuisberg; 🇧🇪 Leuven, Vlaams-Brabant, Belgium