Efficacy Study of Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Large Fibroids

This study has been completed.
Sponsor:
Collaborator:
InSightec-TxSonics
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00159328
First received: September 9, 2005
Last updated: August 12, 2008
Last verified: August 2008
  Purpose

The purpose of this study is to determine whether ablation of uterine fibroids with MR guided focused ultrasound following 3 months pre-treatment with Gonadotrophin releasing analogues will allow the effective use of this therapy in women with larger fibroids.


Condition Intervention Phase
Uterine Fibroids
Procedure: Magnetic Resonance Guided Focused Ultrasound
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase 4 Study of Magnetic Resonance Guided Focused Ultrasound Surgery Following Gonadotrophin Releasing Hormone Agonist Treatment for Symptomatic Uterine Fibroids

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Symptom improvement as judged by validated disease specific questionnaire

Secondary Outcome Measures:
  • Change in fibroid and uterine volume.

Estimated Enrollment: 50
Study Start Date: March 2003
Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject has given consent
  • Willing and able to attend all visits
  • Minimum age 18 with no desire for future fertility
  • Uterine fibroid > 300 cc on MRI
  • Normal cervical smear
  • Screening symptom score >21
  • Pre or peri-menopausal
  • Fibroids being device accessible

Exclusion Criteria:

  • Pregnancy
  • Previous GNRH treatment
  • HRT use
  • Hormonal Contraception
  • Patient on dialysis
  • Haematocrit <25
  • ASA score > 2
  • Severe cerebrovascular disease
  • Anticoagulated
  • Active pelvic infection or history of PID
  • Weight> 250 lbs
  • Any contra-indication to MR imaging
  • Intolerance to MRI contrast agent
  • Unable to remain in prone positions for 3hours
  • IUCD
  • Abdominal scarring in beam pathway
  • Breast feeding
  • Non-perfused fibroid on contrast enhanced images
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159328

Locations
United Kingdom
Department of Interventional Magnetic Resonance, St Mary's Hospital
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
InSightec-TxSonics
Investigators
Principal Investigator: wady m gedroyc St Mary's Hospital, Imperial College London.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00159328     History of Changes
Other Study ID Numbers: UF008
Study First Received: September 9, 2005
Last Updated: August 12, 2008
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
Magnetic Resonance Guided Focused Ultrasound
Gonadotrophin Releasing Hormone Agonist
Uterine Fibroids

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

ClinicalTrials.gov processed this record on September 18, 2014