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Sponsors and Collaborators: |
Artann Laboratories National Cancer Institute (NCI) University of Medicine and Dentistry New Jersey Mayo Clinic University of Minnesota |
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Information provided by: | Artann Laboratories |
ClinicalTrials.gov Identifier: | NCT00822952 |
The purpose of this study is to evaluate an imaging capability Prostate Mechanical Imager (PMI), a PC-based device utilizing a transrectal probe with pressure sensor arrays and motion tracking system, aimed at providing composite elasticity images of the prostate.
Condition |
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Prostatic Neoplasms Prostatic Hyperplasia |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Prostate Mechanical Imager (PMI) Clinical Bridging Study |
Estimated Enrollment: | 40 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
The clinical application of a Prostate Mechanical Imaging (PMI) technique for prostate assessment is examined in this study. PMI technology is based on the visualization of internal structures and dimensions of the prostate by measuring mechanical stress patterns on the gland surface with pressure sensor arrays. Temporal and spatial changes in the stress pattern provide information on the hardness of the prostate. Projected patient sample size for the study is 40 men over the age of 21. Patients will be selected for the study if both of the following criteria are met: (1) abnormal DRE findings; and (2) patients who are scheduled for a TRUS-guided prostate biopsy and/ or radical prostatectomy due to an abnormal DRE, and/or increased PSA, and/or other clinical indications. 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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
All adult male patients between over the age of 21 presenting to the participating clinical sites for urologic examination with the DRE detected prostate abnormality and scheduled for a TRUS-guided prostate biopsy and/ or radical prostatectomy due to an abnormal DRE, and/or increased PSA, and/or other clinical indications will be considered for inclusion. All ethnic and racial groups will be included.
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
University of Minnesota/VA Medical Center | |
Minneapolis, Minnesota, United States, 55455 | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, New Jersey | |
Robert Wood Johnson Medical Center | |
New Brunswick, New Jersey, United States, 08903 | |
United States, New York | |
AccuMed Research Associates | |
Garden City, New York, United States, 11530 | |
United States, Pennsylvania | |
Urology Associates of Lancaster | |
Lancaster, Pennsylvania, United States, 17604 |
Principal Investigator: | Armen Sarvazyan, Ph.D., D.Sc. | Artann Laboratories |
Responsible Party: | Artann Laboratories Inc. ( Armen Sarvazyan, PhD, DSc ) |
Study ID Numbers: | PMI-03 |
Study First Received: | January 14, 2009 |
Last Updated: | July 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00822952 History of Changes |
Health Authority: | United States: Institutional Review Board |
Hyperplasia Prostatic Diseases Genital Neoplasms, Male Prostatic Hyperplasia |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Hyperplasia Neoplasms by Site Pathologic Processes Prostatic Diseases |
Genital Neoplasms, Male Prostatic Hyperplasia Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |