Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization
|ClinicalTrials.gov Identifier: NCT01514617|
Recruitment Status : Unknown
Verified October 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was: Active, not recruiting
First Posted : January 23, 2012
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Leiomyomas||Procedure: Diffusion -and perfusion weighted MRI including iv contrast agent injection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2016|
- Procedure: Diffusion -and perfusion weighted MRI including iv contrast agent injection
MRI is a technique based on magnetic fields and does not require the use of ionizing radiation. Although there are no known side effects associated with MRI, a few precautions should be taken because of the 3T magnetic field. This implicates that all metal and magnetized objects must be removed from the patients before entering the MRI room. Patients with a pacemaker, a cardiac defibrillator or other implanted conductors/prostheses are for reason not eligible for the study.
During the MRI examination, an intravenous contrast agent will be administered. In most cases, patients do not experience any discomfort and the use of this contrast agent is part of the clinical routine.Other Name: Dotarem
- 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. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514617
|Leuven, Belgium, 3000|
|Principal Investigator:||Geert Maleux, MD, Prof.||University Hospital Gasthuisberg, department of Interventional Radiology|