Status:
COMPLETED
Safety Evaluation of ExAblate MRgFUS for Prostate Cancer
Lead Sponsor:
InSightec
Conditions:
Prostate Cancer
Eligibility:
MALE
Up to 75 years
Phase:
PHASE1
Brief Summary
Evaluate the safety, compatibility and imaging quality of the 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 deliv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00811265
Start Date
January 1 2009
End Date
June 1 2013
Last Update
March 8 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sheba Medical Center
Tel Litwinsky, Israel