Prostate Mechanical Imager (PMI) Clinical Bridging Study

Prostatic Neoplasms Clinical Trial

— PMI  

Official title:

Prostate Mechanical Imager (PMI) Clinical Bridging Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822952
• Other study ID #: PMI-03
• Secondary ID: 5R44CA082620
• Status: Completed
• Phase: N/A
• First received: January 14, 2009
• Last updated: March 28, 2014
• Start date: October 2008
• Est. completion date: September 2009

Study information

• Verified date: March 2014
• Source: Artann Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	AccuMed Research Associates	Garden City	New York
United States	Urology Associates of Lancaster	Lancaster	Pennsylvania
United States	University of Minnesota/VA Medical Center	Minneapolis	Minnesota
United States	Robert Wood Johnson Medical Center	New Brunswick	New Jersey
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (5)

Lead Sponsor	Collaborator
Artann Laboratories	Mayo Clinic, National Cancer Institute (NCI), Rutgers, The State University of New Jersey, University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate Mechanical Imager provides reconstructed image of prostate		1 Year	Yes
Secondary	Prostate Mechanical Imager recorded images of prostate are consistent with the abnormal digital rectal examination findings		1 Year	Yes

External Links

•   Artann Laboratories
•   ProUroCare Medical