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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Stanford University
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University Identifier:
First received: March 8, 2012
Last updated: October 23, 2015
Last verified: October 2015
The purpose of our study is to image human prostate tissue using a transrectal photoacoustic imaging probe.

Prostate Cancer

Study Type: Observational
Study Design: 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 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 ] [ Designated as safety issue: No ]
    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: December 2016
Estimated Primary Completion Date: December 2016 (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
Genders 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

Contact: Sri Rajashekar Kothapalli, PhD (650) 724-4948
Contact: Geoffrey Sonn, MD

United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Stanford Cancer Clinical Trials Office    650-498-7061   
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  22701 
Study First Received: March 8, 2012
Last Updated: October 23, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration processed this record on May 26, 2016