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NCT Number: NCT07168785

[18F]-AraG PET Imaging in LA HNSCC

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC) Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Locally Advanced Head and Neck Squamous Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

Location contact

Kathryn I Lauer

CONTACT

[email protected]

(317) 962-8969

Richard Zellars, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥18 years of age.
  • Ability to provide written informed consent and HIPAA authorization.
  • 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 35 fractions, delivered over 5 days a week for 7 weeks, as well as planned weekly cycles of cisplatin (CDDP).
  • Tumor stage III and IV (AJCC 8th edition).
  • Unresectable cases.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Willing and able to maintain the imaging protocol.
  • Patients planning to receive pre-CRT and post-CRT FDG PET/CT scans as part of the standard clinical practice.

Exclusion criteria

  • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the PET/CT scan.
  • Pregnant or breastfeeding.
  • Patients that will receive definitive induction chemotherapy or surgery.
  • Patients who are unable to complete the radiation therapy.

Treatment and study plan

[18F]-AraG radiotracer

Drug

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

Chemotherapy

Drug

Concurrent chemoradiotherapy (CRT) with weekly doses of cisplatin.

Radiotherapy

Device

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

Primary outcomes

  1. [18F]-AraG PET/CT uptake and infiltrating cytotoxic T-cell expression.

    Time frame: Week 1 and Week 16

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

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

    Time frame: Pre-treatment

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

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

    Time frame: Pre-treatment and Week 16

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

Secondary outcomes

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

    Time frame: Pre-Treatment

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

  2. 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)

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

  3. [18F]-AraG PET/CT uptake over time and progressive-free survival

    Time frame: up to 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kathryn I Lauer

CONTACT

[email protected]

(317) 962-8969

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • CellSight Technologies, Inc.

Registry information

Official study title

[18F]-AraG PET Imaging for Enhanced Risk Stratification and Chemoradiotherapy Response Assessment in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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