Status:
COMPLETED
Novel MRI Strategies as a Non-invasive Biomarker in Women With Uterine Fibroids
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
NHS Lothian
Conditions:
Fibroid
Leiomyoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Fibroids are present in up to 80% of women of reproductive age. Associated heavy menstrual bleeding is often an indication for surgery. At present there are no long-term medical treatments for fibroid...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age\>18 years
- Scheduled for hysterectomy with a fibroid uterus
- At least one intramural non-pedunculated, submucosal or subserous fibroid(\>2cm) or multiple small fibroids (uterine volume\>200cm3)
- Ability to understand and willingness to sign consent form
- Normal smear within 3 years
- Exclusion criteria:
- Pregnant or lactating
- Contra indication to MRI
- Unable to tolerate supine position
- Diabetes and/or renal or hepatic impairment
- Contra indication to any of the study medications including gadolinium, MRI contrast
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00746031
Start Date
December 1 2008
End Date
September 1 2010
Last Update
October 25 2010
Active Locations (1)
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1
University of Edinburgh/ Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA