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Spots Global Cancer Trial Database for Novel MRI Strategies as a Non-invasive Biomarker in Women With Uterine Fibroids

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Trial Identification

Brief Title: Novel MRI Strategies as a Non-invasive Biomarker in Women With Uterine Fibroids

Official Title: Novel Magnetic Resonance Imaging Strategies as a Non-invasive Biomarker of Vascular and Extracellular Matrix Morphology in Women With Uterine Fibroids.

Study ID: NCT00746031

Study Description

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 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

University of Edinburgh/ Royal Infirmary of Edinburgh, Edinburgh, , United Kingdom

Contact Details

Name: HILARY OD CRITCHLEY, MBChB;MD;FRCOG

Affiliation: University of Edinburgh

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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