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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01688414
• Other study ID #: VAR0083
• Secondary ID: NCI-2012-01654
• Status: Withdrawn
• Phase: N/A
• First received: September 12, 2012
• Last updated: July 25, 2014
• Start date: September 2012

Study information

• Verified date: July 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bladder Cancer
• Kidney Neoplasms
• Kidney Tumor
• Prostate Cancer

Intervention

Procedure:
• photoacoustic imaging
Undergo PAI
• fluorescence imaging
Undergo fluorescence imaging
• robot-assisted laparoscopic surgery
Undergo robot-assisted laparoscopic surgery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No