Photoacoustic Imaging (PAI) of the Prostate: A Clinical Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Stanford University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- lesion signal intensity on Photoacoustic Imaging (PAI) in relation to different lesion characteristics and the surrounding tissues
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
lesion signal intensity on Photoacoustic Imaging (PAI) in relation to different lesion characteristics and the surrounding tissues
Time Frame: 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 Outcomes
- Measures of hypoxia in the lesion(36 months)