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

NCT00746031 | Completed Phase 4

• 1 other identifier: REC number 08/MRE00/30
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibroid; Leiomyoma

Keywords

MTI; Fibroids; Novel; MR imaging; techniques

Outcome Measures

Primary Outcomes (1)

• Uterine and fibroid volume

  2010

Secondary Outcomes (1)

• Uterine vascular perfusion, vasculature and extracellular matrix (ECM)content of fibroids.

  2010

Study Arms (3)

1

ACTIVE COMPARATOR

GnRH analogue-Zoladex

Drug: GnRH analogue (Zoladex)

2

ACTIVE COMPARATOR

GnRH antagonist plus GnRH analogue

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

3

NO INTERVENTION

Interventions

GnRH analogue (Zoladex) DRUG

3.6mg subcutaneous implant. Monthly doses x 3.

1; 2

GnRH antagonist-Cetrorelix DRUG

Subcutaneous injection 3mg x3 over 7 days

Also known as: Cetrotide

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

University of Edinburgh/ Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24608161 DERIVED

MeSH Terms

Conditions

Leiomyoma

Interventions

Gonadotropin-Releasing Hormone; Goserelin; cetrorelix

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• HILARY OD CRITCHLEY, MBChB;MD;FRCOG

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2008
• First Posted: September 3, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 25, 2010

Record last verified: 2010-10

Locations

GB (1)