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

Sponsors and Collaborators:	Imperial College London InSightec-TxSonics
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00159328

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 IV

MedlinePlus related topics: Ultrasound

Drug Information available for: Gonadorelin Gonadorelin hydrochloride LH-RH

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Phase 4 Study of Magnetic Resonance Guided Focused Ultrasound Surgery Following Gonadotrophin Releasing Hormone Agonist Treatment for Symptomatic Uterine Fibroids

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

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:

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].

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.

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.

Study ID Numbers:	UF008
Study First Received:	September 9, 2005
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00159328
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

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Myofibroma
Connective Tissue Diseases
Leiomyoma

Additional relevant MeSH terms:

Neoplasms, Muscle Tissue
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 14, 2009