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

Sponsor

University of Edinburgh (Other)

Overall Status

Completed

CT.gov ID

NCT00746031

Collaborator

NHS Lothian (Other)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fibroid Leiomyoma	Drug: GnRH analogue (Zoladex) Drug: GnRH antagonist-Cetrorelix	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 GnRH analogue-Zoladex	Drug: GnRH analogue (Zoladex) 3.6mg subcutaneous implant. Monthly doses x 3.
Active Comparator: 2 GnRH antagonist plus GnRH analogue	Drug: GnRH analogue (Zoladex) 3.6mg subcutaneous implant. Monthly doses x 3. Drug: GnRH antagonist-Cetrorelix Subcutaneous injection 3mg x3 over 7 days Other Names: Cetrotide
No Intervention: 3

Arm

Intervention/Treatment

Active Comparator: 1

GnRH analogue-Zoladex

Drug: GnRH analogue (Zoladex)

3.6mg subcutaneous implant. Monthly doses x 3.

Active Comparator: 2

GnRH antagonist plus GnRH analogue

Drug: GnRH analogue (Zoladex)

3.6mg subcutaneous implant. Monthly doses x 3.

Drug: GnRH antagonist-Cetrorelix

Subcutaneous injection 3mg x3 over 7 days

Other Names:

Cetrotide

No Intervention: 3

Outcome Measures

Primary Outcome Measures

Uterine and fibroid volume [2010]

Secondary Outcome Measures

Uterine vascular perfusion, vasculature and extracellular matrix (ECM)content of fibroids. [2010]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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