Safety Evaluation of ExAblate MRgFUS for Prostate Cancer

InSightec

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Device: ExAblate MRgFUS for prostate cancer

Study type: Interventional

Funder types: Industry

Identifiers

NCT00811265

PC001

Details and patient eligibility

About

Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.

Full 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.

Enrollment: 10 estimated patients

Sex: Male

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Simulated ExAblate MRgFUS

Experimental group

Description:

Patients undergoing simulated ExAblate MRgFUS device use

Treatment:

Device: ExAblate MRgFUS for prostate cancer