Transrectal Photoacoustic Imaging of the Prostate

NCT02365883 | Terminated FDA Device

• 2 other identifiers: IRB-21760PROS0044
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Transrectal Imaging

Outcome Measures

Primary Outcomes (1)

• Quality of images obtained

  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

Study Arms (1)

Prostate Cancer Group

Device: Photoacoustic Imaging System

Interventions

Photoacoustic Imaging System DEVICE

manufactured by Endra

Prostate Cancer Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: In order to need a prostatectomy, patient must be male.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Cancer Institute

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Sanjiv S. Gambhir

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: February 19, 2015
• Study Start: September 1, 2011
• Primary Completion: December 16, 2016
• Study Completion: June 3, 2019
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

US (1)