Imaging During Surgery in Diagnosing Patients With Prostate, Bladder, or Kidney Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Utility of Fluorescence and Photoacoustic Imaging Intraoperatively to Assist With Robotic Assisted Minimally Invasive Surgery

Conditions
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Bladder Cancer, Kidney Tumor, Prostate Cancer

Intervention / Treatment
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* Procedure: photoacoustic imaging
* Procedure: fluorescence imaging
* Procedure: robot-assisted laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (fluorescence imaging, PAI)<br>Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery. | Procedure: photoacoustic imaging<br>* Undergo PAI<br>* Other names: PAI;Procedure: fluorescence imaging<br>* Undergo fluorescence imaging<br>Procedure: robot-assisted laparoscopic surgery<br>* Undergo robot-assisted laparoscopic surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |