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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01551576
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 70.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: Hand held transrectal Combined Ultrasound and photoacoustic imaging (PAI) 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 Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Photoacoustic Imaging (PAI) of the Prostate: A Clinical Feasibility Study
• Actual Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Dec 16, 2019
• Actual Study Completion Date: Dec 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
photoacoustic imaging (PAI) Men seen in the urology clinic for elevated PSA and/or abnormal digital rectal exam (DRE) will be offered PAI at the time of transrectal ultrasound guided biopsy, which is standard of care. In addition, patients with a biopsy proven prostate cancer may also be approached for this PAI scan	Device: Hand held transrectal Combined Ultrasound and photoacoustic imaging (PAI) probe; Hand held transrectal Combined Ultrasound and photoacoustic imaging (PAI) probe. PAI is a non-ionizing imaging technique

Outcome Measures

Primary Outcome Measures

1. lesion signal intensity on Photoacoustic Imaging (PAI) in relation to different lesion characteristics and the surrounding tissues [36 months]

   measure of the lesion signal intensity on PAI in relation to different lesion characteristics and the surrounding tissues. The average signal intensity (or more specifically the SNR) of the lesions measured in dB) will be tabulated against lesion depth from the transducer, and lesion size, based on ultrasound measurements

Secondary Outcome Measures

1. Measures of hypoxia in the lesion [36 months]

   total lesion hemoglobin concentration (HbT) at PAI and percentage SO2 (oxygen saturation) in region of interest (ROI) (average and maximum) which will be tested against lesion characteristics based on histology at pathological examination of the biopsy and/or prostatectomy specimen if the patients proceed to have radical prostatectomy performed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Consent signed

• Male >= 18 and <= 80 years of age

• Patients must have an elevated PSA And/ Or Abnormal digital rectal exam Or Other indication for prostate biopsy Or Patients with biopsy proven prostate cancer who are scheduled for prostatectomy.

Exclusion Criteria:

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

• Men with anatomic abnormalities or previous surgical history that make transrectal imaging impossible (for example, men with previous abdominal-perineal bowel resections or anal atresia/stenosis)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Cancer Institute	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Andrei H Iagaru, MD, PhD, Stanford University
• Principal Investigator: Martin Karl Schneider, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT01551576
• Other Study ID Numbers: IRB-22701; SU-03012012-9209; PROS0046
• First Posted: Mar 12, 2012
• Last Update Posted: Nov 2, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Nov 2, 2021