Prostate Mechanical Imager (PMI) Clinical Bridging Study
NCT ID: NCT00822952
Last Updated: 2014-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
71 participants
OBSERVATIONAL
2008-10-31
2009-09-30
Brief Summary
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Detailed Description
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The study is designed to assess the imaging capability of the PMI in three clinical sites, performed by four physicians. Each clinical investigator will perform PMI examination on 10 respective patients with DRE detected abnormality. Pathology data will be collected from TRUS-guided biopsy or radical prostatectomy and will be used as reference data in case there is a discrepancy between the DRE findings and PMI images. Study Hypothesis: Proportion of patients with PMI reconstructed image is anticipated to be consistent with the 84% imaging capability demonstrated in the previous clinical study conducted with the prior version of the PMI device.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* males 21 years of age or older,
* able to withstand body positioning for the entire length of examination,
* presence of DRE detected abnormality,
* scheduled for TRUS-biopsy or surgical removal or prostate,
* able to comprehend, sign, and date the written informed consent form (ICF)
Exclusion Criteria
* significant hip and / vertebral arthritis,
* rectal Crohn's disease,
* locally disseminated cancer of pelvic structure,
* anal fissure, anal fistula, infected anal fistula,
* anal cancer,
* rectal cancer,
* 1st, 2nd or 3rd degree hemorrhoids,
* pelvic irradiation,
* dehydrated impacted stool,
* no vulnerable patients such as students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity will be included in the study
21 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Rutgers, The State University of New Jersey
OTHER
Mayo Clinic
OTHER
University of Minnesota
OTHER
Artann Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Armen Sarvazyan, Ph.D., D.Sc.
Role: PRINCIPAL_INVESTIGATOR
Artann Laboratories
Locations
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University of Minnesota/VA Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Robert Wood Johnson Medical Center
New Brunswick, New Jersey, United States
AccuMed Research Associates
Garden City, New York, United States
Urology Associates of Lancaster
Lancaster, Pennsylvania, United States
Countries
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References
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Weiss RE, Egorov V, Ayrapetyan S, Sarvazyan N, Sarvazyan A. Prostate mechanical imaging: a new method for prostate assessment. Urology. 2008 Mar;71(3):425-9. doi: 10.1016/j.urology.2007.11.021.
Related Links
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Artann Laboratories
Other Identifiers
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PMI-03
Identifier Type: -
Identifier Source: org_study_id