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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

September 1, 2008
October 22, 2010
December 2008
September 2010   (final data collection date for primary outcome measure)
Uterine and fibroid volume [ Time Frame: 2010 ] [ Designated as safety issue: No ]
Feasibility and reproducibility of use of structural, dynamic contrast and magnetization transfer (MTI) MR imaging to visualize and quantify changes in uterus and fibroid volume [ Time Frame: 2010 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00746031 on ClinicalTrials.gov Archive Site
Uterine vascular perfusion, vasculature and extracellular matrix (ECM)content of fibroids. [ Time Frame: 2010 ] [ Designated as safety issue: No ]
Feasibility and reproducibility of use of structural, dynamic contrast and magnetization transfer (MTI) MR imaging to visualize and quantify changes in uterine vascular perfusion vasculature and extracellular matrix (ECM content of fibroids). [ Time Frame: 2010 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
  • Fibroid
  • Leiomyoma
  • 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
  • Active Comparator: 1
    GnRH analogue-Zoladex
    Intervention: Drug: GnRH analogue (Zoladex)
  • Active Comparator: 2
    GnRH antagonist plus GnRH analogue
    Interventions:
    • Drug: GnRH analogue (Zoladex)
    • Drug: GnRH antagonist-Cetrorelix
  • No Intervention: 3
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00746031
REC number 08/MRE00/30
No
PROFESSOR HILARY OD CRITCHLEY, UNIVERSITY OF EDINBURGH
University of Edinburgh
NHS Lothian
Principal Investigator: HILARY OD CRITCHLEY, MBChB;MD;FRCOG University of Edinburgh
University of Edinburgh
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP