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| ID | Type | Description | Link |
|---|---|---|---|
| SU-03012012-9209 | Other Identifier | Stanford University | |
| PROS0046 | Other Identifier | OnCore |
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The purpose of our study is to image human prostate tissue using a transrectal photoacoustic imaging probe.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of hypoxia in the lesion | 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 | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Andrei H Iagaru, MD, PhD | Stanford University | Principal Investigator |
| Martin Karl Schneider, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Cancer Institute | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |