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

This study is currently recruiting participants.
Verified October 2011 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01514617
First received: October 28, 2011
Last updated: January 17, 2012
Last verified: October 2011

October 28, 2011
January 17, 2012
January 2012
December 2014   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01514617 on ClinicalTrials.gov Archive Site
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Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization
Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization

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.

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Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Leiomyomas
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2015
December 2014   (final data collection date for primary outcome measure)

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)
Female
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No
Contact: Geert Maleux, MD, Prof. +32 16 34 05 01 geert.maleux@uzleuven.be
Contact: Katrijn Michielsen, Msc +32 16 34 90 76 katrijn.michielsen@med.kuleuven.be
Belgium
 
NCT01514617
S53666
No
Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Geert Maleux, MD, Prof. University Hospital Gasthuisberg, department of Interventional Radiology
Universitaire Ziekenhuizen Leuven
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP