Safety Evaluation of ExAblate MRgFUS for Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by InSightec.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT00811265
First received: December 17, 2008
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Device: ExAblate MRgFUS for prostate cancer
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety, Compatibility and Imaging Quality of ExAblate Prostate Applicator for Prostate Cancer

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • Device-related adverse events [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Device compatibility with human anatomy [ Time Frame: During simulated device use ] [ Designated as safety issue: Yes ]
  • MR Imaging Quality [ Time Frame: During simulated device use ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: January 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simulated ExAblate MRgFUS
Patients undergoing simulated ExAblate MRgFUS device use
Device: ExAblate MRgFUS for prostate cancer
Simulated use of 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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811265

Locations
Israel
Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: Zohar Dotan       zohar.dotan@sheba.health.gov.il   
Contact: Orith Portnoy       Orith.Portnoy@sheba.health.gov.il   
Sponsors and Collaborators
InSightec
  More Information

Additional Information:
No publications provided

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT00811265     History of Changes
Other Study ID Numbers: PC001
Study First Received: December 17, 2008
Last Updated: September 11, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by InSightec:
ExAblate MRgFUS
Focused ultrasound
Magnetic resonance imaging
Prostate cancer
Radical prostatectomy candidate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014