Prostate Cancer
Conditions
Keywords
ExAblate MRgFUS, Focused ultrasound, Magnetic resonance imaging, Prostate cancer, Radical prostatectomy candidate
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.
Interventions
DEVICEExAblate MRgFUS for prostate cancer
Simulated use of ExAblate MRgFUS system
Sponsors
InSightec
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
No minimum to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device-related adverse events | Throughout study period |
Secondary
| Measure | Time frame |
|---|---|
| Device compatibility with human anatomy | During simulated device use |
| MR Imaging Quality | During simulated device use |
Countries
Israel
Outcome results
None listed