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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00746031
Enrollment
30
Registered
2008-09-03
Start date
2008-12-31
Completion date
2010-09-30
Last updated
2010-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibroid, Leiomyoma

Keywords

MTI, Fibroids, Novel, MR imaging, techniques

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.

Interventions

DRUGGnRH analogue (Zoladex)

3.6mg subcutaneous implant. Monthly doses x 3.

DRUGGnRH antagonist-Cetrorelix

Subcutaneous injection 3mg x3 over 7 days

Sponsors

NHS Lothian
CollaboratorOTHER_GOV
University of Edinburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Uterine and fibroid volume2010

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026