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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fibroid, Leiomyoma

Intervention / Treatment
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* Drug: GnRH analogue (Zoladex)
* Drug: GnRH antagonist-Cetrorelix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>GnRH analogue-Zoladex | Drug: GnRH analogue (Zoladex)<br>* 3.6mg subcutaneous implant. Monthly doses x 3.<br>|
| Active Comparator: 2<br>GnRH antagonist plus GnRH analogue | Drug: GnRH analogue (Zoladex)<br>* 3.6mg subcutaneous implant. Monthly doses x 3.<br>Drug: GnRH antagonist-Cetrorelix<br>* Subcutaneous injection 3mg x3 over 7 days<br>* Other names: Cetrotide;|
| No Intervention: 3<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine and fibroid volume |  | 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine vascular perfusion, vasculature and extracellular matrix (ECM)content of fibroids. |  | 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MTI, Fibroids, Novel, MR imaging, techniques