Safety, Biodistribution and Radiation Dosimetry of [18F]PARPi
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- severity of adverse events
研究概览
简要总结
The purpose of this study is to test the safety of a study drug called PARPi-FL. This drug has been tested in animals but not yet in people. The purpose of this study is to test if a PARPi-FL scan can be used to take pictures of head and neck cancer. The usual approach to imaging this cancer includes several different imaging scans, including x-rays, CT (computed tomography), MRI (magnetic resonance imaging), and PET (positron emission tomography). These tests take pictures of the cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •ECOG performance status 0 or 1
- •Biopsy (histologically or cytologically) proven Squamos Cell Carcinoma
- •Oral cavity, oropharynx, or nasopharynx primary site
- •At least one tumor lesion on standard of care imaging with a minimum diameter of at least 1.5 cm
- •Scheduled to undergo treatment at MSKCC
- •Willingness to sign informed consent
- •Age ≥18 years
- •ECOG performance status 0 or 1
- •Biopsy (histologically or cytologically) proven Squamous Cell Carcinoma
- •Oral cavity,oropharynx, or nasopharynx primary site
- •Scheduled to undergo surgery (neck dissection and/ or neck dissection + surgical removal of the primary) at MSK
- •Willingness to sign informed consent
- •Should have had a standard-of-care [18F]-FDG PET/CT scan before surgery (to minimize the possibility of new alterations developing between the two scans both scans should be acquired within a maximum time difference of one month).
排除标准
- •Significantly impaired organ function that may interfere with the excretion and metabolism of the imaging agent. Specifically, patients will be excluded if they meet the following criteria:
- •Hematologic
- •o Platelets <75K/mcL
- •Bilirubin >2.0 x ULN (institutional upper limits of normal)
- •AST/ALT >2.5 x ULN
- •o Creatinine > 2.0 x ULN
- •Claustrophobia interfering with PET/CT imaging
- •Known allergy to PEG300
- •Pregnancy or breastfeeding
研究组 & 干预措施
Phase I: [18 F]-PARPi and PET/CT Scans
The intervention of this study is the injection of a microdose (< 10 0 ug) of [18 F]- PARPi followed by 3 PET/CT studies to determine the biodistribution of this imaging agent in normal organs as well as the kinetics of uptake in squamous cell carcinomas of the head and neck.
干预措施: [18F]- PARPi (Drug)
Phase II: [18 F]-PARPi and PET/CT Scans
The intervention of this study is the injection of a microdose (< 10 0 ug) of [18 F]- PARPi followed by 3 PET/CT studies to determine the biodistribution of this imaging agent in normal organs as well as the kinetics of uptake in squamous cell carcinomas of the head and neck.
干预措施: [18F]- PARPi (Drug)
Phase I: [18 F]-PARPi and PET/CT Scans
The intervention of this study is the injection of a microdose (< 10 0 ug) of [18 F]- PARPi followed by 3 PET/CT studies to determine the biodistribution of this imaging agent in normal organs as well as the kinetics of uptake in squamous cell carcinomas of the head and neck.
干预措施: PET/CT Scans (Diagnostic Test)
Phase II: [18 F]-PARPi and PET/CT Scans
The intervention of this study is the injection of a microdose (< 10 0 ug) of [18 F]- PARPi followed by 3 PET/CT studies to determine the biodistribution of this imaging agent in normal organs as well as the kinetics of uptake in squamous cell carcinomas of the head and neck.
干预措施: PET/CT Scans (Diagnostic Test)
结局指标
主要结局
severity of adverse events
时间窗: 2 years
according to Common Terminology Criteria for Adverse Events (CTCAE 4.0).
次要结局
未报告次要终点