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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven Identifier:
First received: October 28, 2011
Last updated: December 1, 2015
Last verified: October 2011
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.

Condition Intervention
Procedure: Diffusion -and perfusion weighted MRI including iv contrast agent injection

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization

Resource links provided by NLM:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT01514617

Radiology Department
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Geert Maleux, MD, Prof. University Hospital Gasthuisberg, department of Interventional Radiology
  More Information

Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01514617     History of Changes
Other Study ID Numbers: S53666 
Study First Received: October 28, 2011
Last Updated: December 1, 2015
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Diffusion weighted MRI
Perfusion MRI
Uterine artery embolization
Volumetric Response
Women with symptomatic leiomyomas

Additional relevant MeSH terms:
Body Weight
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Signs and Symptoms processed this record on October 21, 2016