Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01654 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
PI left Stanford
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
This pilot clinical trial studies imaging during surgery in diagnosing patients with prostate, bladder, or kidney cancer. New diagnostic imaging procedures, may find prostate, bladder, or kidney cancer
PRIMARY OBJECTIVES:
I. The primary objective of this pilot study is to assess the ability of fluorescent imaging and photoacoustic imaging (PAI) in a clinical setting to distinguish benign from malignant tissue.
SECONDARY OBJECTIVES:
I. To qualitatively determine the possible benefit of PAI and fluorescent imaging over traditional white light imaging.
OUTLINE:
Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (fluorescence imaging, PAI) | Experimental | Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| photoacoustic imaging | Procedure | Undergo PAI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Margin/lesion status determined by histopathology (cancer status [positive vs negative] as well as grade [Gleason grade 1-5 for prostate cancer, high vs low grade for bladder cancer, and Fuhrman grade 1-4 for kidney cancer]) | The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample. | Up to 6 months after surgery |
| Photoacoustic signal intensity (signal-to-noise ratio in the region of interest) | The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample. The distribution of signal intensity on PAI will be graphed as boxplot. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality. | During the time of surgery |
| Hemoglobin content (lesion total hemoglobin) as determined by photoacoustic measurements | The distribution of signal intensity on hemoglobin content will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality. | During the time of surgery |
| Fluorescence intensity (signal-to-noise ratio in the region of interest) | The distribution of signal intensity on fluorescence intensity will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality. | During the time of surgery |
| Oxygen saturation (percent oxygen saturation in region of interest) as determined by photoacoustic measurements |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective operator determined characteristics for ease of identification of pedicle, NV bundle, and lymph nodes (prostate cancer patients) | Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging). | During the time of surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Gonzalgo | Stanford University | Principal Investigator |
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| fluorescence imaging | Procedure | Undergo fluorescence imaging |
|
| robot-assisted laparoscopic surgery | Procedure | Undergo robot-assisted laparoscopic surgery |
|
The distribution of signal intensity on oxygen saturation will be graphed as boxplots. The investigators will examine these parameters and compare them between malignant and benign cases using Wilcoxon rank-sum tests without making assumptions of normality.
| During the time of surgery |
| Subjective operator determined characteristics for ease of identification of pedicle, ureter, and lymph nodes (bladder cancer patients) | Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging). | During the time of surgery |
| Subjective operator determined characteristics for ease of identification of hilum and tumor (kidney cancer patients) | Descriptive statistics will be used to describe the operator determined secondary endpoints of the utility of each different imaging modality (i.e. white light, PAI, and fluorescence imaging). | During the time of surgery |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D007674 | Kidney Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |