Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome 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.

Outcome 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.

Safety Issue:

No

Principal Investigator

Geert Maleux, MD, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Gasthuisberg, department of Interventional Radiology

Authority:

Belgium: Ethics Committee

Study ID:

S53666

NCT ID:

NCT01514617

Start Date:

January 2012

Completion Date:

July 2015

Related Keywords:

• Leiomyomas
• Leiomyoma
• Diffusion weighted MRI
• Perfusion MRI
• Uterine artery embolization
• Volumetric Response
• Women with symptomatic leiomyomas
• Body Weight
• Leiomyoma
• Myofibroma