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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Prostate Cancer; Bladder Cancer; Kidney Tumor
• Intervention / Treatment: Procedure: photoacoustic imaging; Procedure: fluorescence imaging; Procedure: robot-assisted laparoscopic surgery

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (fluorescence imaging, PAI); Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.	Procedure: photoacoustic imaging; Undergo PAI; Other Names: PAI; optoacoustic imaging; Procedure: fluorescence imaging; Undergo fluorescence imaging; Procedure: robot-assisted laparoscopic surgery; Undergo robot-assisted laparoscopic surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mark Gonzalgo, Stanford University

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 14, 2012
• First Posted (Estimate): September 19, 2012

Study Record Updates

• Last Update Posted (Estimate): July 29, 2014
• Last Update Submitted That Met QC Criteria: July 25, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms
• Other Study ID Numbers: VAR0083; NCI-2012-01654 (Registry Identifier: CTRP (Clinical Trial Reporting Program))