Novel Magnetic Resonance Imaging Strategies as a Non-invasive Biomarker of Vascular and Extracellular Matrix Morphology in Women With Uterine Fibroids.
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Fibroid, Leiomyoma
Female
Fibroid, Leiomyoma
Trial Information
Novel Magnetic Resonance Imaging Strategies as a Non-invasive Biomarker of Vascular and Extracellular Matrix Morphology in Women With Uterine Fibroids.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Uterine and fibroid volume
Outcome Time Frame:
2010
Safety Issue:
No
Principal Investigator
HILARY OD CRITCHLEY, MBChB;MD;FRCOG
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Edinburgh
Authority:
United Kingdom: Research Ethics Committee
Study ID:
REC number 08/MRE00/30
NCT ID:
NCT00746031
Start Date:
December 2008
Completion Date:
September 2010
Related Keywords:
- Fibroid
- Leiomyoma
- MTI
- Fibroids
- Novel
- MR imaging
- techniques
- Leiomyoma
- Myofibroma
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