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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Sanjiv Sam Gambhir, Stanford University
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University Identifier:
First received: March 8, 2012
Last updated: January 27, 2017
Last verified: January 2017
The purpose of our study is to image human prostate tissue using a transrectal photoacoustic imaging probe.

Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Photoacoustic Imaging (PAI) of the Prostate: A Clinical Feasibility Study

Resource links provided by NLM:

Further study details as provided by Sanjiv Sam Gambhir, Stanford University:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 20
Study Start Date: February 2014
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01551576

United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Sri-Rajasekhar Kothapalli   
Contact: Geoffrey Sonn    650-725-5544   
Sub-Investigator: James D Brooks, MD         
Sub-Investigator: Benjamin I Chung, MD         
Sub-Investigator: Harcharan Gill, MD         
Sub-Investigator: Mark L Gonzalgo, MD         
Sub-Investigator: Joseph C Presti, MD         
Sub-Investigator: Geoffrey Sonn, MD         
Sponsors and Collaborators
Stanford University
Principal Investigator: Sanjiv S Gambhir, MD, PhD Stanford University
Principal Investigator: Sri Rajashekar Kothapalli, PhD Stanford University
  More Information

Responsible Party: Sanjiv Sam Gambhir, Chair, Dept Radiology and Director Molecular Imaging Program at Stanford (MIPS), Stanford University Identifier: NCT01551576     History of Changes
Other Study ID Numbers: PROS0046
SU-03012012-9209 ( Other Identifier: Stanford University )
22701 ( Other Identifier: Stanford IRB )
Study First Received: March 8, 2012
Last Updated: January 27, 2017 processed this record on September 19, 2017