Pseudo-Simultaneous Imaging of Tumor Hypoxia and Proliferation in HNC Patients Using PET/CT
Withdrawn before enrolling · Early Phase 1
Conditions studied: Head and Neck Cancer
In brief
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.
Key facts
- Study ID
- NCT03548727
- Run by
- Weill Medical College of Cornell University
- People needed
- 0
- Starts
- 2018-11-01
- Expected to finish
- 2021-11-30
- Last updated by the study team
- 2021-12-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- Citigroup Biomedical Imaging Center — New York, New York, United States
Full record on ClinicalTrials.gov
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