Clinical trial NCT03548727: Pseudo-Simultaneous Imaging of Tumor Hypoxia and Proliferation in HNC Patients Using PET/CT
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Head and Neck Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study includes two arms:

Arm1: FLT PET/CT on Day1 and Day2 Arm2: Combined FMISO/FLT PET/CT on Day1 and FLT PET/CT on Day2
Primary purpose: DIAGNOSTIC

Brief summary: 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 \&lt;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.


Eligibility 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.

Primary outcomes:
measure: Simultaneous Imaging of tumor hypoxia and proliferation
timeFrame: 1 year
Secondary outcomes:
measure: Repeatability of FLT
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Citigroup Biomedical Imaging Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Sadek Nehmeh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: