Prostate Cancer
Conditions
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.
Interventions
DEVICEHand 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
Sponsors
Stanford University
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed