Efficacy Study of Magnetic Resonance (MR) Guided Focused... | NCT00159328

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

NCT00159328

Sponsor

Imperial College London

Status

Completed

Last Update Posted

Aug 13, 2008Estimated

Enrollment

Phase

Phase 4

Conditions

Uterine Fibroids

Interventions

Magnetic Resonance Guided Focused Ultrasound

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2008

Last Update Posted Date

Aug 13, 2008Estimated

Name	Class
InSightec-TxSonics	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Magnetic Resonance Guided Focused Ultrasound	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptom improvement as judged by validated disease specific questionnaire

Secondary Outcomes

Measure	Description	Time Frame
Change in fibroid and uterine volume.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
wady m gedroyc	St Mary's Hospital, Imperial College London.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Interventional Magnetic Resonance, St Mary's Hospital		London		W2 1NY	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15547216	Background	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.
12861137

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms