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

Plain English summary of protocol

Background and study aims
The main purpose of this study is to investigate whether new specialised Magnetic Resonance Imaging (MRI) scans – spectroscopy and diffusion weighted imaging - can detect early changes in uterine fibroids after uterine artery embolisation (UAE) (is a procedure where an radiologist uses a catheter to deliver small particles that block the blood supply to the uterine fibroids). We hope to investigate the effect of UAE using two different materials using these two specialised MRI scans. UAE is a relatively new procedure for women with troublesome fibroids. Although UAE is a successful treatment in the majority of women in about 10-15% of cases we do not succeed in blocking off the blood supply to the fibroid completely. There are several different products (embolic agents) on the market which we use to block off the arteries to the womb. We do not know which the best is or whether they are all equal. They vary in cost and it is possible that one may carry advantages over another in terms of success rate in killing off the fibroid and also minimising the damage to the ovaries. Both the products we are using are established embolic agents used for embolising uterine fibroids both in the UK and other countries.
New MRI sequences may be able to help answer the questions as to how the fibroids behave immediately after they have been treated.

Who can participate?
20 patients referred for routine uterine artery embolisation will be invited to participate.

What does the study involve?
Much of what is involved is simply part of the UAE procedure. The whole study lasts 7 months. Participants will be randomly allocated one of the study agents. This process is carried out by computer and there is a 50% chance of receiving either product. The first out patient visit will last approximately 30 minutes at the hospital and a research nurse will ask questions about health and fibroid related problems. At this point participants will be invited to join the study. Participants are free to pull out at any time. At some point prior to the UAE, ideally in days 2-5 of the menstrual cycle participants will be invited to give a blood sample to measure oestrogen and other hormone levels, which give a measure of ovarian function and reserve. The second visit involves an MRI scan. This is normal practice and the only extra thing is two additional sequences on the scanner, lasting around 30 minutes. The third visit will be for the UAE procedure, which will be carried out using one or other of the study embolic agents. The following day we will perform an extra MRI scan and take another blood test. We will be seeing participants in the out-patient clinic at 1, 6 months. We will repeat the same blood tests at each visit. At approximately 6 months following the UAE procedure we will repeat the MRI scan, this is normal practice (except for the additional two sequences). This helps us assess the fibroids more accurately.

What are the benefits and risks of taking part ?
There will be no immediate direct benefit to those taking part. But there should be benefits to future patients having uterine artery embolisation and to the NHS because the results of the study are likely increase knowledge of the effects of embolisation and comparison of the two agents will provide information on cost effectiveness of embolic agents. There are no specific risks to participating in this study. However, additional time in the MRI scanner can lead to feelings of claustrophobia. The blood tests although straightforward do involve some minor discomfort with the risk of some minor bruising.

Where is the study run from?
Gartnavel General Hospital, Glasgow (UK)

When is the study starting and how long is it expected to run for?
January 2011 to August 2012

Who is funding the research?
British Society of Interventional Radiology (UK)

Who is the main contact?
Professor Jon. G. Moss
Jon.moss@ggc.scot.nhs.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Scotland
• United Kingdom

Study participating centre

Sponsor information

NHS Greater Glasgow and Clyde (UK)
Hospital/treatment centre

Tennent Institute
Western Infirmary
1st Floor 38 Church Street
Glasgow
G11 6NT
Scotland
United Kingdom

"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Charity

Results and Publications

Study outputs

Editorial Notes

22/11/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
09/05/2016: No publications found, verifying study status with principal investigator.