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

Not Applicable

Withdrawn

• Conditions: Bladder Cancer; Kidney Tumor; Prostate Cancer
• Interventions: Procedure: photoacoustic imaging; Procedure: fluorescence imaging; Procedure: robot-assisted laparoscopic surgery

• Registration Number: NCT01688414
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-19
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-25
• Last Update Posted: 2014-07-29
• Primary Completion: 2015-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (fluorescence imaging, PAI)	photoacoustic imaging	Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.
Diagnostic (fluorescence imaging, PAI)	fluorescence imaging	Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.
Diagnostic (fluorescence imaging, PAI)	robot-assisted laparoscopic surgery	Patients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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).
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).