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

NCT ID: NCT03548727

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Repeatability of FLT kinetics

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

Group Type EXPERIMENTAL

PET/CT Imaging

Intervention Type DIAGNOSTIC_TEST

PET/CT Imaging of tumor hypoxia and proliferation

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

Group Type EXPERIMENTAL

PET/CT Imaging

Intervention Type DIAGNOSTIC_TEST

PET/CT Imaging of tumor hypoxia and proliferation

Interventions

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PET/CT Imaging

PET/CT Imaging of tumor hypoxia and proliferation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sadek Nehmeh, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Citigroup Biomedical Imaging Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1703018046

Identifier Type: -

Identifier Source: org_study_id