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临床试验/NCT03548727
NCT03548727撤回1 期

A Pilot Study to Assess the Feasibility of Pseudo-Simultaneous Imaging of Tumor Hypoxia and Proliferation in Head and Neck Cancer Patients Using PET/CT

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
撤回
试验地点
1
主要终点
Simultaneous Imaging of tumor hypoxia and proliferation

研究概览

简要总结

66% of HNC patients present with advanced-stage disease at initial diagnosis. The 5-year survival rates for stages IVa, IVb, and IVc are 32%, 25%, and <4% respectively. Accurate pre-treatment staging is vital in determining the optimum procedure for the management of HNC. Early identification of non-responders may allow modification of their treatment through the introduction of more intensive therapies. Identifying prognostic factors that predict patient outcome will ultimately lead to new treatment regimens. Tumor hypoxia and proliferation are two key characteristics of cancer that were shown to correlate with poor response to treatment in HNC. In this proposal, the investigators assess the prognostic values of these two markers. Combining information from these two biological markers shall result in prognostic information superior to those of any of the two separately. Imaging those vital tumor characteristics simultaneously shall provide more coherent assessment of tumor microenvironment than does registration of corresponding images acquired in different imaging session, thus subject to uncertainties resulting from transient biologic changes and image registration process. The investigators propose to use a method that the investigators previously developed to simultaneously and non-invasively image tumor hypoxia (FMISO-PET) and proliferation (FLT-PET) within a single PET/CT study. CT Perfusion scan will be performed 1st, followed by PET imaging with staggered FMISO and FLT injections. FMISO and FLT signals will be separated retrospectively using kinetic modeling. The investigators believe imaging tumor hypoxia and cell proliferation simultaneously yield information underpinning for image-guided and radiobiological based dose painting, adaptive therapy, and patient medical management. If successful, this pilot study will constitute the basis for a NIH grant proposal that aims to improve treatment outcome assessment in HNC.

研究设计

研究类型
Interventional
分配方式
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

  • •Subject Inclusion Criteria:
  • •Pathologic Confirmation of HNC
  • •No prior treatment for this diagnosis of HNC
  • •Patient to be treated with Radio-Therapy
  • •Age >= 18 years old
  • •Karnofsky performance status >= 70%
  • •Women of childbearing age must have a negative blood pregnancy test.

排除标准

  • •Women who are pregnant or breast-feeding.
  • •Severe diabetes (fasting blood glucose > 200- mg/dl)
  • •Adults who are unable to consent
  • •Patients who do not agree to share and store data History of lack of tolerance of the standard of care FDG-PET scan previously obtained
  • •History of previous intolerance of either FMISO or FLT.

研究组 & 干预措施

Repeatability of FLT kinetics

Experimental

Radiotracer: 18F-FLT Dose: 10 mCi Frequency: Two baseline PET/CT at baseline up to 3 days apart.

干预措施: PET/CT Imaging (Diagnostic Test)

Pseudo-Simultaneous FMISO/FLT PET/CT Imaging

Experimental

Radiotracer: 18F-FLT and 18F-FLT Dose and Frequency: 8 mCi 18F-FLT and 8 mCi 18F-FLT on Day1, the 8mCi 18F-FLT on Day2

干预措施: PET/CT Imaging (Diagnostic Test)

结局指标

主要结局

Simultaneous Imaging of tumor hypoxia and proliferation

时间窗: 1 year

To assess the feasibility to tease out the FMISO and FLT kinetics in simultaneous FMISO/FLT PET/CT imaging. FMISO and FLT kinetic parameters will be measured from the combined FMISO/FLT dynamic study. The accuracy of those measurements will be tested by comparing the FLT kinetic measurements deduced from the combined FMISO/FLT study on day1 with those from the sole FLT study of day2.

次要结局

  • Repeatability of FLT(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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