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Monitor Response to Treatment in Neuroblastoma Using 3&Apos;-Deoxy-3&Apos;-Fluorothymidine- Positron Emission Tomography (FLT-PET)

2017年4月4日 更新者：Zhihong Wang、Barbara Ann Karmanos Cancer Institute

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

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.

研究概览

地位

未知

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (预期的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Michigan
      • Detroit、Michigan、美国、48201
        • 招聘中
        • Children's Hospital of Michigan
        • 接触：
          • Zhihong J Wang, M.D., Ph.D.
          • 电话号码：313-577-5515
        • 接触：
          • Anthony F Shields, M.D., Ph.D.
          • 电话号码：(313) 576-8735
        • 副研究员：
          • Majid Khalaf, M.D.
        • 副研究员：
          • Yaddanapudi Ravindranath, M.D.
        • 副研究员：
          • Diane Chugani, Ph.D.
        • 副研究员：
          • Jeffrey Taub, M.D.
        • 副研究员：
          • Sureyya Savasan, M.D.
        • 副研究员：
          • Roland Chu, M.D.
        • 副研究员：
          • Kanta Bhambhani, M.D.
        • 副研究员：
          • Anthony F Shields, M.D., Ph.D.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1天 至 21年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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 1. 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

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：FLT-PET

Patients will be managed per COG protocol ANBL00B1 (low risk, LR), ANBL0521 (intermediate risk, IR), ANBL0531 (high risk, HR) or other future neuroblastoma studies according to their risk group (risk assignment, treatment schema and protocols are available in COG website). The following is a brief description of the treatment.

  1. Low risk patients: observation only.
  2. Intermediate risk patients: chemotherapy stratified according to risk sub-groups followed by surgical resection.
  3. High risk patients: 6 courses of induction chemotherapy, surgical resection and high dose chemotherapy with autologous stem cell transplant (SCT), involved field radiation and 6 months of Isotrenitoin.

PET scan will be conducted at diagnosis, at the end of the first cycle of treatment and prior to the surgical procedure (resection).
设备：FLT-PET
PET scan will be conducted at diagnosis, at the end of the first cycle of treatment and prior to the surgical procedure (resection).

研究衡量的是什么？

主要结果指标

结果测量
大体时间
To determine whether 18F-FLT-PET is a sensitive tool to image neuroblastoma.
大体时间：1st PET - At diagnosis
1st PET - At diagnosis

次要结果测量

结果测量
大体时间
To evaluate the utility of FLT-PET in early assessment of patient response to treatment.
大体时间：1st PET - At diagnosis
1st PET - At diagnosis
To evaluate the utility of FLT-PET in early assessment of patient response to
大体时间：2nd PET - Approx. 3 wks (end of 1st cycle)
2nd PET - Approx. 3 wks (end of 1st cycle)
To evaluate the utility of FLT-PET in early assessment of patient response to treatment.
大体时间：3rd PET: 6-15 wks (Prior to surgery)
3rd PET: 6-15 wks (Prior to surgery)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Barbara Ann Karmanos Cancer Institute

合作者

Children's Hospital of Michigan

调查人员

  • 首席研究员：Anthony F. Shields, M.D., Ph.D.、Barbara Ann Karmanos Cancer Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年2月1日

初级完成 (预期的)

2018年2月1日

研究完成 (预期的)

2018年2月1日

研究注册日期

首次提交

2011年2月22日

首先提交符合 QC 标准的

2011年3月3日

首次发布 (估计)

2011年3月4日

研究记录更新

最后更新发布 (实际的)

2017年4月6日

上次提交的符合 QC 标准的更新

2017年4月4日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • WSU 2009-031

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