[18F]-AraG PET Imaging in LA HNSCC

September 4, 2025 updated by: Mark Langer, Indiana University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

5

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kathryn I Lauer
  • Phone Number: (317) 962-8969
  • Email: kilauer@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
        • Contact:
        • Principal Investigator:
          • Mark Langer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [18F]-AraG PET/CT scan
[18F]-AraG PET/CT scans to be performed according to the institution's standard of operation, which occurs on the first and sixteenth day of treatment.
Drug: [18F]-AraG radiotracer
[18F]-AraG radiotracer, which occurs on the first and sixteenth day of treatment.
Drug: Chemotherapy
Concurrent chemoradiotherapy (CRT) with weekly doses of cisplatin.
Device: Radiotherapy
Concurrent chemoradiotherapy (CRT) of 70Gy of radiation dose in 33 fractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[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
Week 1 and Week 16
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.
Pre-treatment
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.
Pre-treatment and Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-Treatment
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.
treatment planning through post treatment ( up to 6 months)
[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.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

CellSight Technologies, Inc.

Investigators

  • Principal Investigator: Mark Langer, Indiana University Simon Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

August 27, 2025

First Submitted That Met QC Criteria

September 4, 2025

First Posted (Estimated)

September 11, 2025

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO-IUSCCC-0910

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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