Biodistribution and Pharmacokinetic Study of the Positron Emission Tomography (PET) Radiopharmaceutical [18F]-C-SNAT4
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Biodistribution of [18F]-C-SNAT4
研究概览
简要总结
Primary Objectives
- Determine the biodistribution of [18F]-C-SNAT4 in 5 healthy volunteers. Secondary Objectives
- Determine the dosimetry of [18F]-C-SNAT4 PET in healthy volunteers and patients with lung cancer.
- Determine the acute toxicity of [18F]-C-SNAT4 PET in healthy volunteers and patients with lung cancer.
- Determine whether uptake in [18F]-C-SNAT4 PET imaging is significantly different in tumor and corresponding contralateral noncancer tissue in patients with lung cancer (tested by Wilcoxon test) before the therapy.
- Determine/verify the safety profile of the [18F]-C-SNAT4 radiotracer, as an imaging agent in patients with lung cancer.
- Determine the time of maximal [18F]-C-SNAT4 radiotracer uptake post injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ANC ≥ 1.5 x 109/L without myeloid growth factor support for 7 days preceding lab assessment
- •Hgb ≥ 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if Hgb corrected to ≥ 9 g/dL (90 g/L) as by growth factor or transfusion prior to PET scan
- •Platelet count ≥ 100 x 109/L w/o blood transfusions for 7 days preceding lab assessment
- •Bilirubin ≤ 1.5 x upper limit of normal (ULN) except for pts with documented history of Gilbert's disease
- •ALT ≤ 2.5 x ULN
- •AST ≤ 2.5 x ULN
- •Alkaline phosphatase (AP) ≤ 3 x ULN
- •If a women of childbearing potential (WCBP): negative early pregnancy test (EPT)
- •Karnofsky Performance Status (KPS) ≥ 60
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Has already begun non-surgical therapy for any recurrence, prior to the first [18F]-C-SNAT4 PET/CT scan
- •Severe/uncontrolled inter-current illness within the previous 28 days prior to PET scan.
- •Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation.
- •History of allergic reactions to IV contrasts or reactions attributed to compounds of similar chemical or biological composition to [18F]-C-SNAT4 used in study.
- •Pregnant or nursing
- •Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT bore (diameter 70 cm).
研究组 & 干预措施
Healthy volunteers (Group 1)
Group 1(n = 5) healthy volunteers. Each participant in this part of the study will receive a single dose of [18F]-C-SNAT4 and then undergo three times of whole body (WB) PET/CT scans (Scan 1: 60 minutes dynamic scan; Scan 2: WB skull base-thigh at 90 minutes +/- 10 minutes post injection; Scan 3: WB skull base-thigh at 120 minutes +/- 10 minutes post-injection of [18F]-C-SNAT4).
干预措施: Positron emission tomography (PET)/Computed tomography (CT) Scan (Device)
Patients with newly diagnosed lung cancer (Group 2)
Group2 (n = 5) newly diagnosed lung cancer. Each participant in this part of the study will receive a single dose of [18F]-C-SNAT4 and then undergo three times of whole body (WB) PET/CT scans (Scan 1: 60 minutes dynamic scan; Scan 2: WB skull base-thigh at 90 minutes +/- 10 minutes post injection; Scan 3: WB skull base-thigh at 120 minutes +/- 10 minutes post-injection of [18F]-C-SNAT4).
干预措施: Positron emission tomography (PET)/Computed tomography (CT) Scan (Device)
Patients with lung cancer undergoing non-surgical tx (Group 3)
Group 3 (n = 10) lung cancer after non-surgical therapy. Each participant in this part of the study will receive a total of 2 doses of [18F]-C-SNAT4 (on 2 separate occasions spaced at least 1 week apart, each of which will be followed by undergoing a [18F]-C-SNAT4 PET/CT scan)
干预措施: Positron emission tomography (PET)/Computed tomography (CT) Scan (Device)
Patients with newly diagnosed lung cancer (Group 2)
Group2 (n = 5) newly diagnosed lung cancer. Each participant in this part of the study will receive a single dose of [18F]-C-SNAT4 and then undergo three times of whole body (WB) PET/CT scans (Scan 1: 60 minutes dynamic scan; Scan 2: WB skull base-thigh at 90 minutes +/- 10 minutes post injection; Scan 3: WB skull base-thigh at 120 minutes +/- 10 minutes post-injection of [18F]-C-SNAT4).
干预措施: 18F-C-SNAT4 (Drug)
Healthy volunteers (Group 1)
Group 1(n = 5) healthy volunteers. Each participant in this part of the study will receive a single dose of [18F]-C-SNAT4 and then undergo three times of whole body (WB) PET/CT scans (Scan 1: 60 minutes dynamic scan; Scan 2: WB skull base-thigh at 90 minutes +/- 10 minutes post injection; Scan 3: WB skull base-thigh at 120 minutes +/- 10 minutes post-injection of [18F]-C-SNAT4).
干预措施: 18F-C-SNAT4 (Drug)
Patients with lung cancer undergoing non-surgical tx (Group 3)
Group 3 (n = 10) lung cancer after non-surgical therapy. Each participant in this part of the study will receive a total of 2 doses of [18F]-C-SNAT4 (on 2 separate occasions spaced at least 1 week apart, each of which will be followed by undergoing a [18F]-C-SNAT4 PET/CT scan)
干预措施: 18F-C-SNAT4 (Drug)
结局指标
主要结局
Biodistribution of [18F]-C-SNAT4
时间窗: 1 day
Whole-body \[18F\]-C-SNAT4 PET scans will be performed at 60 min post intravenous injection of the PET tracer in Group 1 of 5 healthy volunteers
次要结局
- Dosimetry of [18F]-C-SNAT4(1 day)
- Toxicity of [18F]-C-SNAT4(7 days)
- 18F]-C-SNAT4 Uptake(1 day)
- The Maximal [18F]-C-SNAT4 Uptake as PET Radiotracer(1 day)
- [18F]-C-SNAT4 PET Imaging Signal in Responders and Non-responders(7 days)