Prostate Mechanical Imager (PMI) Clinical Bridging Study

This study has been completed.
Sponsor:
Collaborators:
Rutgers, The State University of New Jersey
Mayo Clinic
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Artann Laboratories
ClinicalTrials.gov Identifier:
NCT00822952
First received: January 14, 2009
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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
Prostatic Neoplasms
Prostatic Hyperplasia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prostate Mechanical Imager (PMI) Clinical Bridging Study

Resource links provided by NLM:


Further study details as provided by Artann Laboratories:

Primary Outcome Measures:
  • Prostate Mechanical Imager provides reconstructed image of prostate [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Prostate Mechanical Imager recorded images of prostate are consistent with the abnormal digital rectal examination findings [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: October 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • all racial and ethnic groups,
  • 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:

  • previous pelvic surgery,
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822952

Locations
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
Sponsors and Collaborators
Artann Laboratories
Rutgers, The State University of New Jersey
Mayo Clinic
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Armen Sarvazyan, Ph.D., D.Sc. Artann Laboratories
  More Information

Additional Information:
Publications:
Responsible Party: Artann Laboratories
ClinicalTrials.gov Identifier: NCT00822952     History of Changes
Other Study ID Numbers: PMI-03, 5R44CA082620
Study First Received: January 14, 2009
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 21, 2014