Back to resultsSafety Evaluation of ExAblate MRgFUS for Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
ExAblate MRgFUS for prostate cancer
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring ExAblate MRgFUS, Focused ultrasound, Magnetic resonance imaging, Prostate cancer, Radical prostatectomy candidate
Eligibility 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.
Sites / Locations
- Sheba Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Simulated ExAblate MRgFUS
Arm Description
Patients undergoing simulated ExAblate MRgFUS device use
Outcomes
Primary Outcome Measures
Device-related adverse events
Secondary Outcome Measures
Device compatibility with human anatomy
MR Imaging Quality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00811265
Brief Title
Safety Evaluation of ExAblate MRgFUS for Prostate Cancer
Official Title
Safety, Compatibility and Imaging Quality of ExAblate Prostate Applicator for Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InSightec
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 delivered and no focused ultrasound therapy will be performed. This is an imaging only study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
ExAblate MRgFUS, Focused ultrasound, Magnetic resonance imaging, Prostate cancer, Radical prostatectomy candidate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Simulated ExAblate MRgFUS
Arm Type
Experimental
Arm Description
Patients undergoing simulated ExAblate MRgFUS device use
Intervention Type
Device
Intervention Name(s)
ExAblate MRgFUS for prostate cancer
Intervention Description
Simulated use of ExAblate MRgFUS system
Primary Outcome Measure Information:
Title
Device-related adverse events
Time Frame
Throughout study period
Secondary Outcome Measure Information:
Title
Device compatibility with human anatomy
Time Frame
During simulated device use
Title
MR Imaging Quality
Time Frame
During simulated device use
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Sheba Medical Center
City
Tel Hashomer
Country
Israel
12. IPD Sharing Statement
Links:
URL
http://www.insightec.com
Description
Web page of clinical study Sponsor
Learn more about this trial
Safety Evaluation of ExAblate MRgFUS for Prostate Cancer
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