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

NCT01514617 — Not applicable, Unknown, 100 participants, Universitaire Ziekenhuizen KU Leuven

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Registry	NCT01514617
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: single, diagnostic
Enrollment	100 (Estimated)
Sponsor	Universitaire Ziekenhuizen KU Leuven (Other)
Conditions	Leiomyomas
Interventions	Diffusion -and perfusion weighted MRI including iv contrast agent injection (Procedure)
Dates	start 2012-01-01, primary completion 2025-12-01 (estimated), completion 2025-12-01 (estimated), first posted 2012-01-23, last updated 2024-07-10
Locations	1 site in Belgium

-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.

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+Arms and interventions

Diffusion -and perfusion weighted MRI including iv contrast agent injection (Procedure), also known as Dotarem: 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.

+Outcome measures

Primary outcomes

Diffusion -and perfusion weighted MRI as a predictor for volumetric response of leiomyomas after uterine artery embolization [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.]: 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.

+Eligibility

Sex: Female

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)

+Locations (1)

Facility	City	Country	Status
Radiology Department	Leuven	Belgium

+Investigators

Geert Maleux, MD, Prof., Principal investigator, University Hospital Gasthuisberg, department of Interventional Radiology