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Head and Neck Squamous Cell Carcinoma (HNSCC)Early Phase 1NCT07168785

[18F]-AraG PET Imaging in LA HNSCC

A Early Phase 1 study testing [18F]-AraG radiotracer, Chemotherapy and Radiotherapy in people with Head and Neck Squamous Cell Carcinoma (HNSCC) and Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Indiana University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
[18F]-AraG radiotracer, Chemotherapy and Radiotherapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
Sep 2026to Oct 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kathryn I Lauer contact

(317) 962-8969

kilauer@iu.edu

United States1 site

  • Indiana University

    Indianapolis, Indiana, 46202

    Kathryn I Lauer, (317) 962-8969, kilauer@iu.edu

    Richard Zellars, MD

Other trials in United States

About this study

Official title: [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.

Read the 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.

Being tested
[18F]-AraG radiotracer, Chemotherapy, Radiotherapy
Keywords
AraG PET/CT, Chemoradiotherapy, [18F]-AraG PET/CT
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [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.

Study groups in NCT07168785
Study groupRoleWhat they receive
[18F]-AraG PET/CT scanExperimental[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.
Receives: Drug: [18F]-AraG radiotracer; Drug: Chemotherapy; Device: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. [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

    Measured: Week 1 and Week 16

  2. 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.

    Measured: Pre-treatment

  3. 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.

    Measured: Pre-treatment and Week 16

Secondary outcomes (3)

  1. 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.

    Measured: Pre-Treatment

  2. 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.

    Measured: treatment planning through post treatment ( up to 6 months)

  3. [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.

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2025
  2. Study startSep 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07168785
Sponsor's protocol ID
CTO-IUSCCC-0910
Status last verified
Jun 2026
First submitted
27 Aug 2025
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [18F]-AraG radiotracer, Chemotherapy and Radiotherapy in people with Head and Neck Squamous Cell Carcinoma (HNSCC) and Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kathryn I Lauer ((317) 962-8969, kilauer@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[18F]-AraG PET/CT uptake and infiltrating cytotoxic T-cell expression. (time frame: Week 1 and Week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07168785.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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