Clinical trial NCT00746031: Novel MRI Strategies as a Non-invasive Biomarker in Women With Uterine Fibroids
Official title: Novel Magnetic Resonance Imaging Strategies as a Non-invasive Biomarker of Vascular and Extracellular Matrix Morphology in Women With Uterine Fibroids.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibroid
Leiomyoma
Keywords: MTI
Fibroids
Novel
MR imaging
techniques
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2008-09-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: Uterine and fibroid volume
timeFrame: 2010
Secondary outcomes:
measure: Uterine vascular perfusion, vasculature and extracellular matrix (ECM)content of fibroids.
timeFrame: 2010
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh/ Royal Infirmary of Edinburgh
Study officials:
affiliation: University of Edinburgh
name: HILARY OD CRITCHLEY, MBChB;MD;FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munro KI, Thrippleton MJ, Williams AR, McKillop G, Walker J, Horne AW, Newby DE, Anderson RA, Semple SI, Marshall I, Lewis SC, Millar RP, Bastin ME, Critchley HO. Quantitative serial MRI of the treated fibroid uterus. PLoS One. 2014 Mar 7;9(3):e89809. doi: 10.1371/journal.pone.0089809. eCollection 2014.