This trial is active, not recruiting.

Condition leiomyomas
Treatment diffusion -and perfusion weighted mri including iv contrast agent injection
Sponsor Universitaire Ziekenhuizen Leuven
Start date January 2012
End date December 2015
Trial size 100 participants
Trial identifier NCT01514617, S53666


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (investigator)
Primary purpose diagnostic

Primary Outcomes

Diffusion -and perfusion weighted MRI as a predictor for volumetric response of leiomyomas after uterine artery embolization
time frame: 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.

Eligibility Criteria

Female participants of any age.

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)

Additional Information

Official title Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization
Principal investigator Geert Maleux, MD, Prof.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.