Intravital Microscopy (IVM) in Patients With Peritoneal Carcinomatosis (PC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Tumor vessel identification (# tumor vessels visualized per high power field)
研究概览
简要总结
This study will investigate the tumor-associated vasculature of patients with peritoneal carcinomatosis, or cancer that spreads along the inner abdominal lining. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the tumor-associated vessels of peritoneal disease. The IVM observations may determine if an individual patient's tumor vessels would be amenable to receiving systemic therapy, based on the functionality of the vessels.
详细描述
Primary objective(s): To determine the feasibility and clinical utility of performing HIVM in patients with peritoneal carcinomatosis during standard course of treatment (cytoreductive surgery with hyperthermic intraperitoneal chemotherapy, or CRS-HIPEC).
Secondary objective(s):
- Compare the microscopic observation of the tumor-associated vessels with normal tissue (peritoneal surface) in each individual subject.
- Correlate the microscopic observations of the tumor-associated vessels with pathologic grade of tumor implants.
- Correlate the microscopic observation of the microvasculature with tumor-specific and overall survival.
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
盲法说明
This is an open-label, non-randomized, single center, study of IVM observation in conjunction with fluorescein and ICG in subjects with peritoneal carcinomatosis undergoing CRS-HIPEC.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years of age.
- •Have an ECOG Performance Status of ≤
- •Refer to Appendix C.
- •Have measurable disease in the peritoneum by direct visualization (visible lesion typically > 0.5 cm in maximal diameter).
- •Carcinomatosis that meets indications for CRS-HIPEC.
- •Subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
- •A negative skin-prick test to fluorescein.
排除标准
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations.
- •Renal dysfunction as defined as a GFR <
- •Liver dysfunction as defined by Child-Pugh score > 5, or LFT's 1.5x above normal range.
- •Any known allergy or prior reaction to fluorescein or ICG or a positive skin prick test to fluorescein.
- •Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy test.
- •Unwilling or unable to follow protocol requirements.
- •Any condition which in the Investigators' opinion deems the patient unsuitable (e.g., abnormal EKG).
- •Any condition that excludes CRS-HIPEC as the standard of care for the patient.
结局指标
主要结局
Tumor vessel identification (# tumor vessels visualized per high power field)
时间窗: 15-20 minutes
Identify and measure vessels associated with peritoneal tumor implants
Tumor vessel density (# tumor vessels per square cm area observed)
时间窗: 15-20 minutes
Determine vessel density per 10x field
Tumor blood flow (velocity, mm/sec)
时间窗: 15-20 minutes
Calculate the blood flow velocity of the vessels and tissue penetration of fluorescent dyes as markers of vessel permeability.
Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake)
时间窗: 15-20 minutes
Visualize vital dyes within the vessels \[fluorescein and indocyanine green (ICG)\]
次要结局
- Post-operative correlation of the microvasculature with pathologic features of the tumor implants (i.e. tumor grade) at the time of the final pathology report (5-7 days after surgery).(5-7 days)
- Post-operative correlation of the microscopic observation of the tumor microvasculature tumor-specific and overall survival.(5 years)
- Post-operative comparison of the microvasculature of peritoneal carcinomatosis with normal tissue (peritoneum)(15-20 minutes)
研究者
Emmanuel M. Gabriel
Principal Investigator
Mayo Clinic