Study Stopped
PI left Stanford
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
2 other identifiers
interventional
N/A
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 12, 2012
CompletedFirst Posted
Study publicly available on registry
September 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedJuly 29, 2014
July 1, 2014
3 years
September 12, 2012
July 25, 2014
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (3)
Subjective operator determined characteristics for ease of identification of pedicle, NV bundle, and lymph nodes (prostate cancer patients)
During the time of surgery
Subjective operator determined characteristics for ease of identification of pedicle, ureter, and lymph nodes (bladder cancer patients)
During the time of surgery
Subjective operator determined characteristics for ease of identification of hilum and tumor (kidney cancer patients)
During the time of surgery
Study Arms (1)
Diagnostic (fluorescence imaging, PAI)
EXPERIMENTALPatients undergo fluorescence imaging and PAI during robot assisted laparoscopic surgery.
Interventions
Undergo PAI
Undergo robot-assisted laparoscopic surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Cancer Institute (NCI)collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Gonzalgo
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2012
First Posted
September 19, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2015
Last Updated
July 29, 2014
Record last verified: 2014-07