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

This study has been completed.
Sponsor:
Collaborator:
NHS Lothian
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00746031
First received: September 1, 2008
Last updated: October 22, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Fibroid
Leiomyoma
 Drug: GnRH analogue (Zoladex)
Drug: GnRH antagonist-Cetrorelix
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Novel Magnetic Resonance Imaging Strategies as a Non-invasive Biomarker of Vascular and Extracellular Matrix Morphology in Women With Uterine Fibroids.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Uterine and fibroid volume [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Uterine vascular perfusion, vasculature and extracellular matrix (ECM)content of fibroids. [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
GnRH analogue-Zoladex
 Drug: GnRH analogue (Zoladex)
3.6mg subcutaneous implant. Monthly doses x 3.
Active Comparator: 2
GnRH antagonist plus GnRH analogue
 Drug: GnRH analogue (Zoladex)
3.6mg subcutaneous implant. Monthly doses x 3.
Drug: GnRH antagonist-Cetrorelix
Subcutaneous injection 3mg x3 over 7 days
Other Name: Cetrotide
No Intervention: 3

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746031

Locations
United Kingdom
University of Edinburgh/ Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: HILARY OD CRITCHLEY, MBChB;MD;FRCOG University of Edinburgh
  More Information

No publications provided

Responsible Party: PROFESSOR HILARY OD CRITCHLEY, UNIVERSITY OF EDINBURGH
ClinicalTrials.gov Identifier: NCT00746031     History of Changes
Other Study ID Numbers: REC number 08/MRE00/30
Study First Received: September 1, 2008
Last Updated: October 22, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
MTI
Fibroids
Novel
MR imaging
techniques

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Cetrorelix
 Goserelin
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013