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NCT00159328 Clinical Trial

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

Uterine Fibroids Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00159328
Other study ID # UF008
Secondary ID
Status Completed
Phase Phase 4
First received September 9, 2005
Last updated August 12, 2008
Start date March 2003
Est. completion date December 2006

Study information
Verified date August 2008
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• Magnetic Resonance Guided Focused Ultrasound

Locations
Country Name City State
United Kingdom Department of Interventional Magnetic Resonance, St Mary's Hospital London

Sponsors (2)
Lead Sponsor Collaborator
Imperial College London InSightec-TxSonics

Country where clinical trial is conducted

United Kingdom, 

References & 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. 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]. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom improvement as judged by validated disease specific questionnaire
Secondary Change in fibroid and uterine volume.
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