Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization

Not Applicable

Active, not recruiting

• Conditions: Leiomyomas

• Registration Number: NCT01514617
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

It is known that volumetric response of leiomyomas following uterine artery embolization correlates well with patients clinical outcome. The aim of this study is to assess diffusion -and perfusion weighted MRI for the prediction of volumetric response following uterine artery embolization in patients with symptomatic leiomyomas.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-28
• Study Start: 2012-01
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• women with symptomatic leiomyomas

Exclusion Criteria

• women with known contra-indications for MRI (cardiac pacemaker, cochlear implants, claustrophobic patients)
• women with contra-indications to gadolinium-based contrast agents (including patients with a known restricted renal function; GFR < 30 mL/min)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Diffusion -and perfusion weighted MRI as a predictor for volumetric response of leiomyomas after uterine artery embolization	Participants will be followed for the duration of hospital stay (an expected average of 3 days) and will be systematically followed during their follow-up.	Patients will be scanned before (baseline) and after (the day of embolization, 3 days and 3 months after embolization). Measurements of signal intensity (SI) will be performed placing ROIs in the central portion of the lesion avoiding areas of artifact. Apparent diffusion coefficients (ADCs) will be calculated at different time points (before and after embolization). Signal intensity measurements on the dynamic contrast enhanced imaging data sets will be performed.

Trial Locations

Locations (1)

Radiology Department; 🇧🇪 Leuven, Belgium