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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01551576
First received: March 8, 2012
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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


Condition
Prostate Cancer

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

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: 50
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

PRIMARY OBJECTIVE(S):

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.

SECONDARY OBJECTIVE(S):

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.

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT01551576

Contacts
Contact: Jonathan Wu 650-723-6661 jonathan.ai.wu@gmail.com

Locations
United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Stanford Cancer Clinical Trials Office    650-498-7061    ccto-office@stanford.edu   
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         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sanjiv S Gambhir, MD Stanford University
Principal Investigator: Sri R Kothapalli, MD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01551576     History of Changes
Other Study ID Numbers: PROS0046, SU-03012012-9209, 22701
Study First Received: March 8, 2012
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014