Safety Evaluation of ExAblate MRgFUS for Prostate Cancer

Study Overview
=================
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.

Official Title
-----------------
Safety, Compatibility and Imaging Quality of ExAblate Prostate Applicator for Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: ExAblate MRgFUS for prostate cancer


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simulated ExAblate MRgFUS<br>Patients undergoing simulated ExAblate MRgFUS device use | Device: ExAblate MRgFUS for prostate cancer<br>* Simulated use of ExAblate MRgFUS system<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related adverse events |  | Throughout study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device compatibility with human anatomy |  | During simulated device use | 
| MR Imaging Quality |  | During simulated device use | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ExAblate MRgFUS, Focused ultrasound, Magnetic resonance imaging, Prostate cancer, Radical prostatectomy candidate