[18F]-AraG PET Imaging in LA HNSCC

Early Phase 1Not Yet RecruitingNCT07168785

Indiana University5 enrolled

Overview

This study will use \[18F\]-AraG PET/CT scans to monitor patients who have been diagnosed with locally advanced Head and Neck Squamous Cell carcinoma (LA-HNSCC), and are planning to undergo standard of care chemoradiotherapy for treatment.

Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer globally. Definitive chemoradiotherapy (CRT) remains the standard of care (SOC) treatment for LA-HNSCC, yet some patients are unsuccessfully treated. The purpose of this study is to explore the feasibility and possible function of \[18F\]-AraG PET/CT (a diagnostic procedure that uses a radioactive tracer \[A method that uses radioactive substances to make pictures of areas inside the body\] to image tumors and assess response to treatment) scans performed before and during treatment to monitor response in patients undergoing chemoradiotherapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

[18F]-AraG radiotracerDRUG

\[18F\]-AraG radiotracer, which occurs on the first and sixteenth day of treatment.

ChemotherapyDRUG

Concurrent chemoradiotherapy (CRT) with weekly doses of cisplatin.

RadiotherapyDEVICE

Concurrent chemoradiotherapy (CRT) of 70Gy of radiation dose in 33 fractions.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Patients ≥18 years of age. 2. Ability to provide written informed consent and HIPAA authorization. 3. LA-HNSCC in the larynx, hypopharynx, or human papillomavirus (HPV) negative oropharynx and is planning to receive definitive CRT as the SOC treatment, which includes a total of 70 Gy of radiation dose in 33 fractions, delivered over 5 days a week for 7 weeks, as well as planned weekly cycles of cisplatin (CDDP). 4. Tumor stage III and IV (AJCC 8th edition). 5. Unresectable cases. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 7. Willing and able to maintain the imaging protocol. 8. Patients planning to receive pre-CRT and post-CRT FDG PET/CT scans as part of the standard clinical practice. Exclusion Criteria 1. Diagnosis of immunodeficiency or receiving systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the PET/CT scan. 2. Pregnant or breastfeeding. 3. Patients that will receive definitive induction chemotherapy or surgery. 4. Patients who are unable to complete the radiation therapy.

Locations (1)

Indiana University

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

[18F]-AraG PET/CT uptake and infiltrating cytotoxic T-cell expression.

Examining the distribution of \[18F\]-AraG PET SUV metrics and counts of CD3+/CD8+/PD1- and CD3+/CD8+/PD1+ T-cells

Time frame: Week 1 and Week 16

Pre-treatment [18F]-AraG PET/CT uptake and clinical response.

Correlation of pre-treatment \[18F\]-AraG PET/CT metrics (such as SUVmax, mean and uptake volume) and clinical response.

Time frame: Pre-treatment

Changes between pre-treatment and mid-treatment [18F]-AraG PET/CT uptake and clinical response

Correlation between percentage changes in PET uptake values (max, mean, and peak) at pre- and mid-CRT and treatment response categories.

Time frame: Pre-treatment and Week 16

Secondary Outcomes

Individual cytotoxic T-cell activities (CD3+, CD8+, PD1-, and PD1+) and pre-treatment [18F]-AraG PET/CT uptake

Correlation between individual cytotoxic T-cell activities (CD3+, CD8+, PD1-, and PD1+) and pre-treatment \[18F\]-AraG PET/CT uptake.

Time frame: Pre-Treatment

Tumor extent and standard uptake values between FDG PET and [18F]-AraG PET/CT imaging

Identify accuracy in tumor extent and standard uptake values between FDG PET and \[18F\]-AraG PET/CT imaging.

Time frame: treatment planning through post treatment ( up to 6 months)

[18F]-AraG PET/CT uptake over time and progressive-free survival

Association between the pattern of change in \[18F\]-AraG PET/CT uptake over time and progressive-free survival.

Time frame: up to 6 months

Central Contacts

Kathryn I Lauer

CONTACT

(317) 962-8969 kilauer@iu.edu

Data from ClinicalTrials.gov

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