Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization
Primary Purpose
Leiomyomas
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Diffusion -and perfusion weighted MRI including iv contrast agent injection
Sponsored by
About this trial
This is an interventional diagnostic trial for Leiomyomas focused on measuring Leiomyoma, Diffusion weighted MRI, Perfusion MRI, Uterine artery embolization, Volumetric Response, Women with symptomatic leiomyomas
Eligibility 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)
Sites / Locations
- Radiology Department
Outcomes
Primary Outcome Measures
Diffusion -and perfusion weighted MRI as a predictor for volumetric response of leiomyomas after uterine artery embolization
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01514617
First Posted
October 28, 2011
Last Updated
December 1, 2015
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT01514617
Brief Title
Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization
Official Title
Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyomas
Keywords
Leiomyoma, Diffusion weighted MRI, Perfusion MRI, Uterine artery embolization, Volumetric Response, Women with symptomatic leiomyomas
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Diffusion -and perfusion weighted MRI including iv contrast agent injection
Other Intervention Name(s)
Dotarem
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diffusion -and perfusion weighted MRI as a predictor for volumetric response of leiomyomas after uterine artery embolization
Description
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.
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.
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert Maleux, MD, Prof.
Organizational Affiliation
University Hospital Gasthuisberg, department of Interventional Radiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiology Department
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization
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