Safety Evaluation of ExAblate MRgFUS for Prostate Cancer

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Device: ExAblate MRgFUS for prostate cancer

• Registration Number: NCT00811265
• Lead Sponsor: InSightec

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.

Study Timeline

• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Study Start: 2009-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Simulated ExAblate MRgFUS	ExAblate MRgFUS for prostate cancer	Patients undergoing simulated ExAblate MRgFUS device use

Primary Outcome Measures

Name	Time	Method
Device-related adverse events	Throughout study period

Secondary Outcome Measures

Name	Time	Method
MR Imaging Quality	During simulated device use
Device compatibility with human anatomy	During simulated device use

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel