Transrectal Photoacoustic Imaging of the Prostate

June 10, 2022 updated by: Stanford University
The purpose of this study is to image human prostate tissue using a new transrectal photoacoustic imaging probe and correlate this with ultrasound and MRI imaging performed once the specimen has been surgically removed. We hope to see what we can visualize with our device as this has never been done before. Eventually, we hope to use a similar device to image the prostate in men being seen by their doctor for prostate cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

English-speaking men at the Palo Alto Veterans Hospital between the ages of 18 and 80 years with clinically localized prostate cancer who desire prostatectomy.

Description

Inclusion Criteria:

  • Diagnosed with clinically-localized prostate cancer
  • Participant desires prostatectomy
  • Male
  • Patient receiving treatment at Palo Alto Veterans Administration (VA) Hospital
  • Age 18 to 80 years old
  • English-speaking

Exclusion Criteria:

  • Cannot tolerate a surgical prostatectomy due to medical comorbidities
  • Cannot give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prostate Cancer Group
Device: Photoacoustic Imaging System
manufactured by Endra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of images obtained
Time Frame: 18 months
Pilot study to better understand the quality of both ultrasound and photo acoustic images that can be obtained using a transrectal instrument. To understand acquisition parameters that help optimize the image quality.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Sanjiv S. Gambhir, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2011

Primary Completion (Actual)

December 16, 2016

Study Completion (Actual)

June 3, 2019

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

February 11, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Actual)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 10, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-21760
  • PROS0044 (Other Identifier: OnCore)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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