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

NCT01551576 | Completed DMC

• 3 other identifiers: IRB-22701SU-03012012-9209PROS0046
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• lesion signal intensity on Photoacoustic Imaging (PAI) in relation to different lesion characteristics and the surrounding tissues

  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

  36 months

Secondary Outcomes (1)

• Measures of hypoxia in the lesion

  36 months

Study Arms (1)

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

Interventions

Hand held transrectal Combined Ultrasound and photoacoustic imaging (PAI) probe DEVICE

Hand held transrectal Combined Ultrasound and photoacoustic imaging (PAI) probe. PAI is a non-ionizing imaging technique

photoacoustic imaging (PAI)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Cancer Institute

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Andrei H Iagaru, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Martin Karl Schneider, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 12, 2012
• Study Start: February 1, 2014
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)