Bladder Cancer, Kidney Tumor, Prostate Cancer
Conditions
Brief summary
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
Detailed description
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.
Interventions
PROCEDUREphotoacoustic imaging
Undergo PAI
PROCEDUREfluorescence imaging
Undergo fluorescence imaging
PROCEDURErobot-assisted laparoscopic surgery
Undergo robot-assisted laparoscopic surgery
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have a pathologic confirmation of prostate cancer, bladder cancer, or kidney cancer based on previous biopsies or procedures OR a strong concern for a kidney malignancy based on computed tomography (CT) or magnetic resonance imaging (MRI) imaging * Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Patients with a surgical history or anatomic variant that would preclude robot assisted laparoscopic approaches to their surgery (i.e. history of ventral hernia repair with mesh) * Patients with medical co-morbidities who cannot tolerate laparoscopic surgery secondary to intra-abdominal carbon dioxide insufflation * Patients with documented allergy or adverse drug reaction to indocyanine green or baseline serum creatinine greater than 1.5 mg/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen saturation (percent oxygen saturation in region of interest) as determined by photoacoustic measurements | During the time of 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. |
| Photoacoustic signal intensity (signal-to-noise ratio in the region of interest) | During the time of surgery | 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. |
| Hemoglobin content (lesion total hemoglobin) as determined by photoacoustic measurements | During the time of surgery | 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. |
| Fluorescence intensity (signal-to-noise ratio in the region of interest) | During the time of surgery | 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. |
| 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]) | Up to 6 months after surgery | The average lesion signal intensity on PAI and fluorescent imaging will be tested against the histology at pathological examination of the tissue sample. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective operator determined characteristics for ease of identification of pedicle, ureter, and lymph nodes (bladder cancer patients) | During the time of surgery | 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). |
| Subjective operator determined characteristics for ease of identification of hilum and tumor (kidney cancer patients) | During the time of surgery | 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). |
| Subjective operator determined characteristics for ease of identification of pedicle, NV bundle, and lymph nodes (prostate cancer patients) | During the time of surgery | 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). |
Outcome results
None listed