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:
Universitaire Ziekenhuizen Leuven
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
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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
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 |
ClinicalTrials.gov processed this record on May 23, 2013