NM404 as an Imaging Agent in Patients With Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Qualitative Image Analysis of NSCLC tumors with 124I-NM404 imaging agent
研究概览
简要总结
This study seeks to determine imaging characteristics of radiolabelled 131-I-NM404 in ten patients with cancer, including calculations of PKs, radiation dosimetry, biodistribution, and optimal imaging times (part 1 - complete).
In addition, specific tumor accumulation and metabolic fate of 131-I-NM404 will be determined in NSCLC tumors collected in 5 patients (part 2 - complete). Lastly, the study will collect preliminary data on imaging NSCLC tumors in up to 12 patients with evaluable disease (part 3 - ongoing).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented NSCLC with measurable of disease
- •Disease is evaluable by CT scan
- •At least 18 years old. Women cannot be pregnant or breastfeeding
- •Karnofsky score >/= to 60
- •Adequate renal/hepatic function
- •Adequate blood cell count levels
排除标准
- •Concomitant infection
- •Other active cancers
研究组 & 干预措施
Diagnostic: iodine I-124 NM404 CT/PET scan
Patients undergo iodine I-124 NM404 CT/PET scan at 1-2, 4-6, 24, and 48 hours and at 5-10 days.
干预措施: I124-NM404 (Drug)
结局指标
主要结局
Qualitative Image Analysis of NSCLC tumors with 124I-NM404 imaging agent
时间窗: 5 days
The objective of this protocol is to obtain preliminary data on imaging NSCLC tumors. Images with 124I-NM404 will be evaluated by a nuclear medicine consultant, who will be blind to the participants' clinical findings and other radiographic images. The nuclear medicine consultant will independently record his findings, and then compare his results with those obtained by conventional FDG-PET imaging that was done at baseline as part of this study. This comparison will be only qualitative.
次要结局
- Semi-quantitative lesion scoring to evaluate Tumor biodistribution(up to 7 days)