Safety Evaluation of ExAblate MRgFUS for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811265
• Other study ID #: PC001
• Status: Completed
• Phase: Phase 1
• First received: December 17, 2008
• Last updated: March 7, 2016
• Start date: January 2009
• Est. completion date: June 2013

Study information

• Verified date: March 2016
• Source: InSightec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• ExAblate MRgFUS for prostate cancer
Simulated use of ExAblate MRgFUS system

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device-related adverse events		Throughout study period	Yes
Secondary	Device compatibility with human anatomy		During simulated device use	Yes
Secondary	MR Imaging Quality		During simulated device use	No

External Links

•   Web page of clinical study Sponsor