Transrectal Photoacoustic Imaging of the Prostate

NCT ID: NCT02365883

Last Updated: 2022-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2019-06-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prostate Cancer Group

Photoacoustic Imaging System

Intervention Type DEVICE

manufactured by Endra

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Photoacoustic Imaging System

manufactured by Endra

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sanjiv S. Gambhir

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University Cancer Institute

Stanford, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PROS0044

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-21760

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Targeted Fusion Biopsy of the Prostate
NCT02744534 COMPLETED PHASE2
MRI Guided Prostate Biopsy
NCT06302595 RECRUITING NA
Phase II Laser Focal Therapy of Prostate Cancer
NCT02243033 ACTIVE_NOT_RECRUITING