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

NCT03548727 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: 1703018046
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Simultaneous Imaging of tumor hypoxia and proliferation

  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.

  1 year

Secondary Outcomes (1)

• Repeatability of FLT

  1 year

Study Arms (2)

Repeatability of FLT kinetics

EXPERIMENTAL

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

Diagnostic Test: PET/CT Imaging

Pseudo-Simultaneous FMISO/FLT PET/CT Imaging

EXPERIMENTAL

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

Interventions

PET/CT Imaging DIAGNOSTIC_TEST

PET/CT Imaging of tumor hypoxia and proliferation

Pseudo-Simultaneous FMISO/FLT PET/CT Imaging; Repeatability of FLT kinetics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Citigroup Biomedical Imaging Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Sadek Nehmeh, Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: June 7, 2018
• Study Start: November 1, 2018
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

US (1)