Photoacoustic Imaging (PAI) of the Prostate: A Clinical Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01551576
Recruitment Status : Suspended (logistics)
First Posted : March 12, 2012
Last Update Posted : November 9, 2017
Information provided by (Responsible Party):
Stanford University

Brief Summary:
The purpose of our study is to image human prostate tissue using a transrectal photoacoustic imaging probe.

Condition or disease
Prostate Cancer

Detailed Description:


The primary objective of this pilot study is to assess PAI-performance in a clinical setting to understand limitations of our current PAI instrumentation and to help improve the next-generation design.


To do preliminary evaluations of oxygen saturation in lesions based on PAI-measurements in order to distinguish malignant from benign prostatic tissue as a basis for future studies.

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Photoacoustic Imaging (PAI) of the Prostate: A Clinical Feasibility Study
Study Start Date : February 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. lesion signal intensity on Photoacoustic Imaging (PAI) in relation to different lesion characteristics and the surrounding tissues [ Time Frame: 36 months ]
    The types of measures can be divided into three groups: 1) Operator determined measures during or just after the examination; 2) Post processing measures determined during post processing of the captured data and images; 3) Measures related to standard imaging and histopathological examination.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Medical oncologists with appropriate patient populations will be informed of the study and the inclusion and exclusion criteria. Potential participants will be recruited from the Stanford Urologic Oncology Clinic. A study investigator will follow-up with participants who are interested in participating in this study. Study information will be posted on the Stanford Cancer Center website as well.

Inclusion Criteria:

  • Consent signed
  • Male >= 18 and <= 80 years of age
  • Choose to proceed with transrectal ultrasound (TRUS) and prostate biopsy

Exclusion Criteria:

  • History of prostatectomy or other surgical history that would preclude transrectal imaging (i.e. abdominal perineal resection), anal stenosis/stricture disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01551576

United States, California
Stanford University Cancer Institute
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Sanjiv S Gambhir, MD, PhD Stanford University
Principal Investigator: Sri Rajashekar Kothapalli, PhD Stanford University

Responsible Party: Stanford University Identifier: NCT01551576     History of Changes
Other Study ID Numbers: PROS0046
SU-03012012-9209 ( Other Identifier: Stanford University )
22701 ( Other Identifier: Stanford IRB )
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017