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

Stanford University

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: Hand held transrectal Combined Ultrasound and photoacoustic imaging (PAI) probe

Study type: Observational

Funder types: Other

Identifiers

NCT01551576

SU-03012012-9209 (Other Identifier)

IRB-22701

PROS0046

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

20 participants in 1 patient group

photoacoustic imaging (PAI)

Description:

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

Treatment:

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