Diffusion Weighted MRI and MRI spectroscopy in the assessment of Uterine Artery Embolisation (UAE): a comparison between a temporary (GelFoam) and a permanent (Embospheres) embolic agent

Not Applicable

Completed

• Conditions: Symptomatic uterine fibroids; Cancer; Leiomyoma of uterus

• Registration Number: ISRCTN67347987
• Lead Sponsor: HS Greater Glasgow and Clyde (UK)

Brief Summary

2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30687808 (added 22/11/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2012-08-31
• Study Start: 2012-11-15
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

1. Symptomatic fibroids
2. MRI shows fibroids are greater than 2cm in diameter
3. Willing to be randomised

Exclusion Criteria

1. Severe allergy to radiographic contrast
2. Active infection
3. Contra-indication or unable to tolerate MRI
4. Unable or unwilling to comply with protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diffusion weighted magnetic resonance imaging and spectroscopy of fibroids pre-embolisation and at 24hrs and 6 months post embolisation to detect changes in the fibroid uterus in both arms (Gelfoam and Embospheres)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Ovarian function and ovarian follicle reserve at baseline, 24hrs, 1 month and 6 months (Luteinising hormone, Follicle stimulating hormone, Anti-mullerian hormone)<br> 2. Cost-effectiveness comparison Gelfoam, Embospheres<br>