Safety Evaluation of ExAblate MRgFUS for Prostate Cancer - Full Text View

Sponsored by:	InSightec
Information provided by:	InSightec
ClinicalTrials.gov Identifier:	NCT00811265

Purpose

Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.

Condition	Intervention	Phase
Prostate Cancer	Device: ExAblate MRgFUS for prostate cancer	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Safety, Compatibility and Imaging Quality of ExAblate Prostate Applicator for Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by InSightec:

Primary Outcome Measures:

Device-related adverse events [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Device compatibility with human anatomy [ Time Frame: During simulated device use ] [ Designated as safety issue: Yes ]
MR Imaging Quality [ Time Frame: During simulated device use ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	January 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Simulated ExAblate MRgFUS: Experimental Patients undergoing simulated ExAblate MRgFUS device use	Device: ExAblate MRgFUS for prostate cancer Simulated use of ExAblate MRgFUS system

Detailed Description:

The objective of this study is to evaluate safety, compatibility and imaging quality of the ExAblate MRgFUS system for prostate cancer, under simulated use conditions. No acoustic energy will be delivered and no focused ultrasound therapy will be performed. This is an imaging only study.

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age of patients: up to 75 years.
Men scheduled for radical prostatectomy due to prostate cancer.
Patients who are able and willing to give consent and able to attend all study visits.

Exclusion Criteria:

Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)
Severely abnormal coagulation (INR>1.5)
Patients with unstable cardiac status including: unstable angina pectoris on medication, patients with documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic), patients on anti-arrhythmic drugs, severe hypertension (diastolic BP > 100 on medication), and patients with cardiac pacemakers
Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hrs.)
Any rectal pathology preventing probe insertion, (as active proctitis, ulcerative colitis, fissure ani, diverticulitis, previous rectal surgery, IBD, etc…)
Any spinal pathology that prohibits maintaining supine position for more then an hour
Any previous radiation to the pelvis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811265

Locations

Israel
Sheba Medical Center	Recruiting
Tel Hashomer, Israel
Contact: Zohar Dotan zohar.dotan@sheba.health.gov.il
Contact: Orith Portnoy Orith.Portnoy@sheba.health.gov.il

Sponsors and Collaborators

InSightec

More Information

Additional Information:

Web page of clinical study Sponsor This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	InSightec ( Nadir Alikacem )
Study ID Numbers:	PC001
Study First Received:	December 17, 2008
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00811265 History of Changes
Health Authority:	Israel: Ethics Commission

Keywords provided by InSightec:

ExAblate MRgFUS
Focused ultrasound
Magnetic resonance imaging
Prostate cancer
Radical prostatectomy candidate

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 03, 2009