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Prostate Mechanical Imager (PMI) Clinical Bridging Study


N/A
21 Years
N/A
Not Enrolling
Male
Prostatic Neoplasms, Prostatic Hyperplasia

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Trial Information

Prostate Mechanical Imager (PMI) Clinical Bridging Study


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Prostate Mechanical Imager provides reconstructed image of prostate

Outcome Time Frame:

1 Year

Safety Issue:

Yes

Principal Investigator

Armen Sarvazyan, Ph.D., D.Sc.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Artann Laboratories

Authority:

United States: Institutional Review Board

Study ID:

PMI-03

NCT ID:

NCT00822952

Start Date:

October 2008

Completion Date:

September 2009

Related Keywords:

  • Prostatic Neoplasms
  • Prostatic Hyperplasia
  • Prostatic Hyperplasia
  • Neoplasms
  • Hyperplasia
  • Prostatic Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905
Urology Associates of LancasterLancaster, Pennsylvania  17604
AccuMed Research AssociatesGarden City, New York  11530
University of Minnesota/VA Medical CenterMinneapolis, Minnesota  55455
Robert Wood Johnson Medical CenterNew Brunswick, New Jersey  08903