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New imaging agent could sharpen cancer treatment decisions

NCT ID NCT07168785

Diagnosis Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This early-phase study will test a new radioactive tracer called [18F]-AraG in just 5 people with advanced head and neck cancer. Participants will receive two PET/CT scans (before and during standard chemoradiotherapy) to see if the tracer's uptake matches immune cell activity and predicts treatment response. The goal is to improve risk assessment, not to treat the cancer directly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
[18F]-AraG radiotracer (a radioactive dye for PET scans)
What this could lead to
If successful, this could lead to a more accurate way to predict how well head and neck cancer responds to chemoradiotherapy, helping doctors tailor treatment.
What could go wrong
This is a very early, tiny study (only 5 people) testing a new imaging agent. It is not designed to prove the tracer improves outcomes, only to see if it correlates with immune activity and response.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 5 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 35 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.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck squamous cell carcinoma HNSCC Locally advanced head and neck squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Indiana University

    Indianapolis, Indiana, 46202, United States

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