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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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
Leiomyomas
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

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: July 2015
Estimated Primary Completion Date: December 2014 (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
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514617

Contacts
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

Locations
Belgium
Radiology Department Recruiting
Leuven, Belgium, 3000
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   
Principal Investigator: Geert Maleux, MD, Prof         
Sub-Investigator: Katrijn Michielsen, Msc         
Sub-Investigator: Frederik De Keyzer, Msc         
Sub-Investigator: Vincent Vandecaveye, MD, Prof         
Sub-Investigator: Katya Op de beeck, MD         
Sub-Investigator: Raymond Oyen, MD, Prof         
Sub-Investigator: Dirk Timmerman, MD, Prof         
Sub-Investigator: Willy Poppe, MD, Prof         
Sub-Investigator: Jasper Verguts, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Geert Maleux, MD, Prof. University Hospital Gasthuisberg, department of Interventional Radiology
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01514617     History of Changes
Other Study ID Numbers: S53666
Study First Received: October 28, 2011
Last Updated: January 17, 2012
Health Authority: Belgium: Ethics Committee

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

Additional relevant MeSH terms:
Body Weight
Leiomyoma
Myofibroma
Signs and Symptoms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014