Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01551576
Recruitment Status : Suspended (logistics)
First Posted : March 12, 2012
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date March 8, 2012
First Posted Date March 12, 2012
Last Update Posted Date August 19, 2019
Study Start Date February 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 9, 2012)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Photoacoustic Imaging (PAI) of the Prostate: A Clinical Feasibility Study
Official Title Photoacoustic Imaging (PAI) of the Prostate: A Clinical Feasibility Study
Brief Summary The purpose of our study is to image human prostate tissue using a transrectal photoacoustic imaging probe.
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: October 21, 2015)
20
Original Estimated Enrollment
 (submitted: March 9, 2012)
50
Estimated Study Completion Date June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01551576
Other Study ID Numbers PROS0046
SU-03012012-9209 ( Other Identifier: Stanford University )
22701 ( Other Identifier: Stanford IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Sanjiv S Gambhir, MD, PhD Stanford University
Principal Investigator: Martin Karl Schneider, PhD Stanford University
PRS Account Stanford University
Verification Date August 2019