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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02365883
Other study ID # IRB-21760
Secondary ID PROS0044
Status Terminated
Phase
First received
Last updated
Start date September 2011
Est. completion date June 3, 2019

Study information

Verified date June 2022
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 22
Est. completion date June 3, 2019
Est. primary completion date December 16, 2016
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Photoacoustic Imaging System
manufactured by Endra

Locations

Country Name City State
United States Stanford University Cancer Institute Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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