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

University of Edinburgh

Status and phase: Completed; Phase 4

Conditions: Leiomyoma; Fibroid

Treatments: Drug: GnRH antagonist-Cetrorelix; Drug: GnRH analogue (Zoladex)

Study type: Interventional

Funder types: Other

Identifiers

NCT00746031

REC number 08/MRE00/30

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

30 participants in 3 patient groups

1

Active Comparator group

Description:

GnRH analogue-Zoladex

Treatment:

Drug: GnRH analogue (Zoladex)

2

Active Comparator group

Description:

GnRH antagonist plus GnRH analogue

Treatment:

Drug: GnRH analogue (Zoladex)

Drug: GnRH antagonist-Cetrorelix

3

No Intervention group