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OpenTrials
Completed

NCT Number: NCT00746031

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Edinburgh/ Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GnRH analogue (Zoladex)

Drug

3.6mg subcutaneous implant. Monthly doses x 3.

GnRH antagonist-Cetrorelix

Drug

Subcutaneous injection 3mg x3 over 7 days

Other names: Cetrotide

Primary outcomes

  1. Uterine and fibroid volume

    Time frame: 2010

Secondary outcomes

  1. Uterine vascular perfusion, vasculature and extracellular matrix (ECM)content of fibroids.

    Time frame: 2010

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 3, 2008
Registry last updated
Oct 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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