NCT00159328

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

August 13, 2008

Status Verified

August 1, 2008

First QC Date

September 9, 2005

Last Update Submit

August 12, 2008

Conditions

Uterine Fibroids

Keywords

Magnetic Resonance Guided Focused UltrasoundGonadotrophin Releasing Hormone AgonistUterine Fibroids

Outcome Measures

Primary Outcomes (1)

  • Symptom improvement as judged by validated disease specific questionnaire

Secondary Outcomes (1)

  • Change in fibroid and uterine volume.

Interventions

Magnetic Resonance Guided Focused UltrasoundPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Interventional Magnetic Resonance, St Mary's Hospital

London, W2 1NY, United Kingdom

Location

Related Publications (3)

  • Hindley J, Gedroyc WM, Regan L, Stewart E, Tempany C, Hynyen K, Mcdannold N, Inbar Y, Itzchak Y, Rabinovici J, Kim HS, Geschwind JF, Hesley G, Gostout B, Ehrenstein T, Hengst S, Sklair-Levy M, Shushan A, Jolesz F. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol. 2004 Dec;183(6):1713-9. doi: 10.2214/ajr.183.6.01831713.

    PMID: 15547216BACKGROUND

  • Stewart EA, Gedroyc WM, Tempany CM, Quade BJ, Inbar Y, Ehrenstein T, Shushan A, Hindley JT, Goldin RD, David M, Sklair M, Rabinovici J. Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol. 2003 Jul;189(1):48-54. doi: 10.1067/mob.2003.345.

    PMID: 12861137BACKGROUND

  • Tempany CM, Stewart EA, McDannold N, Quade BJ, Jolesz FA, Hynynen K. MR imaging-guided focused ultrasound surgery of uterine leiomyomas: a feasibility study. Radiology. 2003 Mar;226(3):897-905. doi: 10.1148/radiol.2271020395.

    PMID: 12616023BACKGROUND

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • wady m gedroyc

    St Mary's Hospital, Imperial College London.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

March 1, 2003

Study Completion

December 1, 2006

Last Updated

August 13, 2008

Record last verified: 2008-08

Locations

GB(1)