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

Leiomyomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01514617
• Other study ID #: S53666
• Status: Active, not recruiting
• Phase: N/A
• First received: October 28, 2011
• Last updated: December 1, 2015
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: October 2011
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Leiomyoma
• Leiomyomas

Intervention

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.

Locations

Country	Name	City	State
Belgium	Radiology Department	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	No