Pilot Study to Determine the Utility of [18F] 3&Apos;-Deoxy-3&Apos;-Fluorothymidine- Positron Emission Tomography in Monitoring Patient Response to Chemotherapy in Neuroblastoma
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To determine whether 18F-FLT-PET is a sensitive tool to image neuroblastoma.
研究概览
简要总结
The purpose of this study is to gain knowledge about how to best diagnose and treat tumors, how tumors affect normal tissue and how treatment of tumors with radiation therapy and chemotherapy affect tumors.
详细描述
The purpose of this research study is to observe the changes within the tumor cells which may improve the understanding of how tumors grow and how they respond to various treatments. These changes will be compared with results of the physical examination and scans (CT and MRI) that are done as part of clinical care. Images will be made showing the distribution throughout the body of substances containing a small amount of radioactive material. This procedure is called a PET scan. The radioactive substances (tracer compound) in this study are [F-18] FLT.
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
- 1 Day 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with neuroblastoma or suspected neuroblastoma seen at Children's Hospital of Michigan (CHM). Patients need to be 2 years or older to be eligible for the initial study
- •Patients must be 1 day to 21 years old, there is no gender limit.
- •Diagnosis: All patients with neuroblastoma or suspected neuroblastoma, including newly diagnosed and relapsed patients, are eligible for Objective
- •To be eligible for Objective 2, patients must have a diagnosis of neuroblastoma verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, and have measurable disease after the initial surgery
- •Female adolescent patients must have a negative pregnancy test within 14 days of first imaging and should not be pregnant
- •Patients must be able to lie still for the tests, or have no contraindication for sedation
- •Patients or their legal guardian must sign an informed consent indicating that they are aware of the investigational nature of this study
- •A total number of 40-50 patients will be included in the study
排除标准
- •Patients who do not have a histology diagnosis of neuroblastoma are not eligible for the study
- •Patients whose definite diagnosis after surgery is not consistent with the diagnosis of neuroblastoma will be included in the Objective 1 but excluded for Objective 2.
结局指标
主要结局
To determine whether 18F-FLT-PET is a sensitive tool to image neuroblastoma.
时间窗: 1st PET - At diagnosis
次要结局
- To evaluate the utility of FLT-PET in early assessment of patient response to treatment.(3rd PET: 6-15 wks (Prior to surgery))
- To evaluate the utility of FLT-PET in early assessment of patient response to(2nd PET - Approx. 3 wks (end of 1st cycle))
研究者
Zhihong Wang
Principal Investigator
Barbara Ann Karmanos Cancer Institute