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

Primary Purpose

Uterine Fibroids

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Magnetic Resonance Guided Focused Ultrasound

About this trial

This is an interventional diagnostic trial for Uterine Fibroids focused on measuring Magnetic Resonance Guided Focused Ultrasound, Gonadotrophin Releasing Hormone Agonist, Uterine Fibroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Department of Interventional Magnetic Resonance, St Mary's Hospital

Outcomes

Primary Outcome Measures

Symptom improvement as judged by validated disease specific questionnaire

Secondary Outcome Measures

Change in fibroid and uterine volume.

Full Information

NCT ID

NCT00159328

First Posted

September 9, 2005

Last Updated

August 12, 2008

Sponsor

Imperial College London

Collaborators

InSightec-TxSonics

1. Study Identification

Unique Protocol Identification Number

NCT00159328

Brief Title

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

Official Title

Phase 4 Study of Magnetic Resonance Guided Focused Ultrasound Surgery Following Gonadotrophin Releasing Hormone Agonist Treatment for Symptomatic Uterine Fibroids

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Imperial College London

Collaborators

InSightec-TxSonics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Fibroids

Keywords

Magnetic Resonance Guided Focused Ultrasound, Gonadotrophin Releasing Hormone Agonist, Uterine Fibroids

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Magnetic Resonance Guided Focused Ultrasound

Primary Outcome Measure Information:

Title

Symptom improvement as judged by validated disease specific questionnaire

Secondary Outcome Measure Information:

Title

Change in fibroid and uterine volume.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

wady m gedroyc

Organizational Affiliation

St Mary's Hospital, Imperial College London.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Interventional Magnetic Resonance, St Mary's Hospital

City

London

ZIP/Postal Code

W2 1NY

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

15547216

Citation

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. Erratum In: AJR Am J Roentgenol. 2005 Jan;184(1):348. Hynnen, Kullvro [corrected to Hynyen, Kullervo]; Macdanold, Nathan [corrected to Mcdannold, Nathan]; Kim, Kevin [corrected to Kim, Hyun S]; Gostout, Brian [corrected to Gostout, Bobbie].

Results Reference

background

PubMed Identifier

12861137

Citation

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.

Results Reference

background

PubMed Identifier

12616023

Citation

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.

Results Reference

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

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