Prostatic NeoplasmsPMINCT00822952
Prostate Mechanical Imager (PMI) Clinical Bridging Study
An observational study of Prostatic Neoplasms and Prostatic Hyperplasia, run by Artann Laboratories at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostatic Hyperplasia
- How many people
- 71 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2008to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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,
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
AccuMed Research Associates
Garden City, New York, 11530
Urology Associates of Lancaster
Lancaster, Pennsylvania, 17604
University of Minnesota/VA Medical Center
Minneapolis, Minnesota, 55455
Robert Wood Johnson Medical Center
New Brunswick, New Jersey, 08903
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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.
Read the 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.
- Conditions
- Prostatic Neoplasms, Prostatic Hyperplasia
- Medical subject headings
- Prostatic Neoplasms, Prostatic Hyperplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate Mechanical Imager provides reconstructed image of prostate
Measured: 1 Year
Secondary outcomes (1)
Prostate Mechanical Imager recorded images of prostate are consistent with the abnormal digital rectal examination findings
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artann Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Rutgers, The State University of New Jersey, Mayo Clinic, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Armen Sarvazyan, Ph.D., D.Sc., Principal investigator, Artann Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822952
- Sponsor's protocol ID
- PMI-03
- Other IDs
- 5R44CA082620
- Acronym
- PMI
- Status last verified
- Mar 2014
- First submitted
- 14 Jan 2009
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18342178
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Mechanical Imager (PMI) Clinical Bridging Study
- ClinicalTrials.gov ID
- NCT00822952
- Acronym / sponsor ID
- PMI / PMI-03
- Conditions
- Prostatic Neoplasms, Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Artann LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Rutgers, The State University of New Jersey, Mayo Clinic, University of Minnesota
- Study start
- Oct 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prostate Mechanical Imager provides reconstructed image of prostate
Time frame: 1 Year
1 secondary outcome
Prostate Mechanical Imager recorded images of prostate are consistent with the abnormal digital rectal examination findings
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
- Background: PubMed 18342178Weiss 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.
- Artann LaboratoriesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armen Sarvazyan, Ph.D., D.Sc. principal investigator
Artann Laboratories
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms and Prostatic Hyperplasia, run by Artann Laboratories at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate Mechanical Imager provides reconstructed image of prostate (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00822952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2014.