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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746031
• Other study ID #: REC number 08/MRE00/30
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2008
• Last updated: October 22, 2010
• Start date: December 2008
• Est. completion date: September 2010

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fibroid
• Leiomyoma

Intervention

Drug:
• GnRH analogue (Zoladex)
3.6mg subcutaneous implant. Monthly doses x 3.
• GnRH antagonist-Cetrorelix
Subcutaneous injection 3mg x3 over 7 days

Locations

Country	Name	City	State
United Kingdom	University of Edinburgh/ Royal Infirmary of Edinburgh	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

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