Safety Evaluation of ExAblate MRgFUS for Prostate Cancer
This study is currently recruiting participants.
Verified September 2012 by InSightec
Sponsor:
InSightec
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT00811265
First received: December 17, 2008
Last updated: September 11, 2012
Last verified: September 2012
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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
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 Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013