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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03548727
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : December 18, 2019
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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 <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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Diagnostic Test: PET/CT Imaging Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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

Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Repeatability of FLT kinetics
Radiotracer: 18F-FLT Dose: 10 mCi Frequency: Two baseline PET/CT at baseline up to 3 days apart.
Diagnostic Test: PET/CT Imaging
PET/CT Imaging of tumor hypoxia and proliferation

Experimental: Pseudo-Simultaneous FMISO/FLT PET/CT Imaging
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
Diagnostic Test: PET/CT Imaging
PET/CT Imaging of tumor hypoxia and proliferation

Primary Outcome Measures :
  1. Simultaneous Imaging of tumor hypoxia and proliferation [ Time Frame: 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.

Secondary Outcome Measures :
  1. Repeatability of FLT [ Time Frame: 1 year ]
    To assess the repeatability of FLT kinetics. Subjects will undergo two dynamic FLT PET studies up to 3 days apart. The repeatability of the corresponding kinetic parameters from the two studies will be measured using statistical methods (e.g. Bland-Altman analysis)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03548727

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Contact: Sadek Nehmeh, Ph.D. 212-746-4645

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United States, New York
Citigroup Biomedical Imaging Center Recruiting
New York, New York, United States, 10021
Contact: Sadek Nehmeh, Ph.D.    212-746-4645   
Sponsors and Collaborators
Weill Medical College of Cornell University
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Principal Investigator: Sadek Nehmeh, Ph.D. Weill Medical College of Cornell University
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Responsible Party: Weill Medical College of Cornell University Identifier: NCT03548727    
Other Study ID Numbers: 1703018046
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Signs and Symptoms, Respiratory
Signs and Symptoms