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

Phase 1
75 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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.

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Device-related adverse events

Outcome Time Frame:

Throughout study period

Safety Issue:



Israel: Ethics Commission

Study ID:




Start Date:

January 2009

Completion Date:

June 2013

Related Keywords:

  • Prostate Cancer
  • ExAblate MRgFUS
  • Focused ultrasound
  • Magnetic resonance imaging
  • Prostate cancer
  • Radical prostatectomy candidate
  • Prostatic Neoplasms