Utility of Fluorescence and Photoacoustic Imaging Intraoperatively to Assist With Robotic Assisted Minimally Invasive Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- Stanford University
- Primary Endpoint
- Fluorescence intensity (signal-to-noise ratio in the region of interest)
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Fluorescence intensity (signal-to-noise ratio in the region of interest)
Time Frame: 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])
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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 Outcomes
- Subjective operator determined characteristics for ease of identification of hilum and tumor (kidney cancer patients)(During the time of surgery)
- 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)