Pseudo-Simultaneous Imaging of Tumor Hypoxia and Proliferation in HNC Patients Using PET/CT

Weill Cornell Medicine (WCM)

Status and phase

Withdrawn

Early Phase 1

Conditions

Head and Neck Cancer

Treatments

Diagnostic Test: PET/CT Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT03548727

1703018046

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Exclusion Criteria:

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.