Intravital Microscopy (IVM) in Human Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- 1. 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 solid tumors. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the vessels associated with solid tumors. 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:
I. To determine the feasibility of performing human intravital microscopy (HIVM) in patients with deep space solid tumors during standard course of surgical resection.
SECONDARY OBJECTIVES:
I. Compare the microscopic observation of the tumor-associated vessels with normal tissue (e.g. peritoneal surface or normal brain tissue) in each individual subject.
II. Correlate the microscopic observations of the tumor-associated vessels with pathologic grade of tumor.
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 in subjects with solid tumors undergoing surgical resection.
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
- •Eastern Cooperative Oncology Group (ECOG)Performance Status of ≤ 2
- •Measurable tumor by direct visualization requiring surgical resection in the operating room (OR)
- •Tumor types of origin include gastric, pancreatic, hepatobiliary, colorectal, sarcoma, brain, or breast cancer that may involve the axillary lymph nodes cancers. Tumors may be primary or metastatic
- •Subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent
- •Subject must have a skin prick test pre-operatively (at the time of the preoperative visit and after signed informed consent for entry into this clinical trial is given) to determine any sensitivity 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 glomerular filtration rate (GFR) < 45
- •Liver dysfunction as defined by Child-Pugh score > 5, or liver function test (LFT)'s 1.5 x above normal range
- •Any known allergy or prior reaction to fluorescein 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 electrocardiography [EKG], including T wave inversion, elevated T waves, prolonged QRS interval, or conduction blocks) or that requires further work-up (including cardiac echo or stress test)
- •Any condition that excludes surgical resection as the standard of care for the patient
研究组 & 干预措施
Arm 1
Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with solid tumors during surgical resection.
干预措施: Diagnostic Microscopy (Device)
Arm 1
Determine the feasibility and clinical utility of performing Human Intravital Microscopy (HIVM) in patients with solid tumors during surgical resection.
干预措施: Fluorescein Sodium Injection (Drug)
结局指标
主要结局
1. Tumor vessel identification (# tumor vessels visualized per high power field)
时间窗: 12-15 minutes
Identify and measure vessels associated with solid tumors
2. Tumor vessel density (# tumor vessels per square cm area observed)
时间窗: 12-15 minutes
Determine vessel density per 10x field
3. Fluorescent dye uptake (# tumor vessels with fluorescent dye uptake and # tumor vessels without dye uptake)
时间窗: 12-15 minutes
Visualize vital dye within the vessels (fluorescein)
4. Tumor blood flow (velocity, mm/sec)
时间窗: 12-15 minutes
Calculate the blood flow velocity of the vessels and tissue penetration of fluorescent dye as a marker of vessel permeability.
次要结局
- 5. Post-operative comparison of the microvasculature of tumor with normal tissue(15-20 minutes)
- 6. 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)