Leiomyoma Clinical Trial
Official title:
Novel Magnetic Resonance Imaging Strategies as a Non-invasive Biomarker of Vascular and Extracellular Matrix Morphology in Women With Uterine Fibroids.
Verified date | October 2010 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
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 fibroids. There is an unmet need for a pharmacologic agent able to reduce
excessive bleeding and other symptoms associated with increased uterine volume, which could
prevent or significantly delay surgery without causing significant unwanted hypoestrogenic
side effects and allow preservation of fertility.
The purpose of this study is to investigate and validate novel MR imaging as a non-invasive
biomarker for monitoring responses to medical interventions aimed at reduction of excessive
menstrual bleeding and decrease in uterine/ fibroid volume. MR imaging is non-invasive, does
not involve ionizing radiation and new techniques have the potential to resolve tissue
detail to near cellular level.
The investigators are aiming to establish the feasibility and reproducibility of novel MR
imaging techniques in the evaluation of treatment response in women with fibroids and to
provide mechanistic information on whether the reduction in blood flow of uterine/fibroid
vasculature in the shrinkage of fibroids is dependent upon subjects being hypoestrogenic.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Edinburgh/ Royal Infirmary of Edinburgh | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | NHS Lothian |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Uterine and fibroid volume | 2010 | No | |
Secondary | Uterine vascular perfusion, vasculature and extracellular matrix (ECM)content of fibroids. | 2010 | No |
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