Utility of Fluorescence and Photoacoustic Imaging Intraoperatively to Assist With Robotic Assisted Minimally Invasive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Fluorescence intensity (signal-to-noise ratio in the region of interest)
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Fluorescence intensity (signal-to-noise ratio in the region of interest)
时间窗: 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])
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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)