Novel MRI Strategies as a Non-invasive Biomarker in Women With Uterine Fibroids
Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
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 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.