[18F]-AraG PET Imaging for Head and Neck Cancer

Overseen By Kathryn I Lauer

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Indiana University

Must be taking: Cisplatin

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Immunodeficiency, Pregnancy, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special imaging method to monitor head and neck cancer treatment. It focuses on using a new type of PET/CT scan with the [18F]-AraG radiotracer to track changes in cancer for patients undergoing standard chemoradiotherapy. The trial specifically targets those with advanced squamous cell carcinoma in the larynx or HPV-negative oropharynx who will receive a specific radiation and chemotherapy plan. Individuals diagnosed with this type of cancer and planning to follow the standard treatment may find this trial suitable. As an Early Phase 1 trial, the research aims to understand how this new imaging method works in people, offering a unique opportunity to contribute to advancements in cancer treatment monitoring.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, you cannot participate if you are on systemic steroid therapy or any immunosuppressive therapy within 7 days before the PET/CT scan.

What prior data suggests that the [18F]-AraG PET/CT scan is safe for monitoring head and neck cancer?

Research shows that [18F]-AraG, a type of imaging agent, is still under study to determine its safety for humans. Currently, there is limited information about its safety in humans. The trial is in an early stage, focusing on the treatment's safety and the body's reaction to it.

Specific information about side effects or problems from using [18F]-AraG in people is not yet available. However, early trials closely monitor participants for any issues. If [18F]-AraG had been approved for another use, it might suggest greater safety, but that is not the case here. By joining this trial, participants contribute to understanding the safety of this imaging agent for future patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

[18F]-AraG PET/CT scans are unique because they use a radiotracer to provide a precise image of head and neck cancer activity. Unlike traditional imaging methods, which often rely on anatomical changes, this technique targets the metabolic activity of the cancer cells. Researchers are excited because this approach could lead to earlier detection and more accurate monitoring of the disease, potentially improving treatment outcomes and personalizing patient care.

What evidence suggests that [18F]-AraG PET/CT scan is effective for monitoring Head and Neck Cancer?

Research has shown that [18F]-AraG is a promising tool for monitoring cancer treatment. This special imaging agent accumulates in active CD8+ T cells, which play a key role in fighting tumors. Studies have found that [18F]-AraG PET scans can reveal different patterns in tumors, indicating interactions between the cancer and immune system. This helps doctors evaluate how well the immune system responds to treatment. Although more research is needed, early findings suggest that [18F]-AraG could be useful in tracking how patients with head and neck cancer respond to therapy. Participants in this trial will undergo [18F]-AraG PET/CT scans to assess these interactions. ^{1 6 7 8 9}

Who Is on the Research Team?

Mark Langer

Principal Investigator

Indiana University Simon Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC) who are about to start standard chemoradiotherapy. Specific eligibility details are not provided, but typically participants must meet certain health criteria.

Inclusion Criteria

I have been diagnosed with advanced head and neck cancer and am planning to undergo standard chemotherapy and radiation treatment.

Willing and able to maintain the imaging protocol

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

I am planning to undergo initial chemotherapy or surgery as my main treatment.

Pregnant or breastfeeding

I cannot complete radiation therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Pre-treatment [18F]-AraG PET/CT scans are performed to assess baseline tumor characteristics and cytotoxic T-cell activities

1 week

1 visit (in-person)

Chemoradiotherapy

Participants undergo standard of care chemoradiotherapy with [18F]-AraG PET/CT scans performed on the first and sixteenth day to monitor treatment response

16 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of progressive-free survival

up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• [18F]-AraG radiotracer

Trial Overview [18F]-AraG PET/CT scans are being tested in this study to see how well they monitor the progress of patients with LA-HNSCC undergoing standard chemoradiotherapy treatments.

How Is the Trial Designed?

Group I: [18F]-AraG PET/CT scan Experimental Treatment 3 Interventions

\[18F\]-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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

CellSight Technologies, Inc.

Industry Sponsor

Trials

18

Recruited

320+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07168785

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9868703/

The other immuno-PET: Metabolic tracers in evaluation of ... 18F-FLT PET does not discriminate between reactive and metastatic lymph nodes in primary head and neck cancer patients. J Nucl Med (2007) 48:726–35. doi ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2018.36.15_suppl.6050

A study to evaluate immunological response to PD-1 ... We evaluated the ability of a PET metabolic tracer ([18F]F-AraG), that preferentially accumulates in activated CD8+ T cells, to assess response ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-12220

[18F]F-AraG PET/CT Imaging in Determining ... [18F]F-AraG is an imaging agent that may help monitor immune system response to CAR T cell therapy with axicabtagene ciloleucel (Yescarta) as part of anticancer ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/62/6/802

18F-AraG PET for CD8 Profiling of Tumors and Assessment of ... Results: In the tumor panel, 18F-AraG revealed strikingly different uptake patterns resembling cancer-immune phenotypes observed in the clinic.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11677833/

Non-[18F]FDG PET-Radiopharmaceuticals in Oncology LAG-3 inhibitors are used in some cancers, such as head and neck cancer, lung cancer, and metastatic melanoma. ... Tracer Kinetics of 18F-FDG in ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-07533

An Investigational Scan ([18F]F-AraG PET/CT) for the ... The purpose of this trial is to find out how the radiotracer called [18F]F-AraG can help investigate changes in cancer's anti-tumor immune response (or ...

8. trial.medpath.com trial.medpath.com/clinical-trial/1c42790d0e9cf0d7/nct07168785-arag-pet-imaging-head-neck-squamous-cell-carcinoma

[18F]-AraG PET Imaging in LA HNSCC - MedPath This study will use \[18F\]-AraG PET/CT scans to monitor patients who have been diagnosed with locally advanced Head and Neck Squamous Cell ...

9. withpower.com withpower.com/trial/early-phase-1-locally-advanced-head-and-neck-squamous-cell-carcinoma-9-2025-00256

[18F]-AraG PET Imaging for Head and Neck Cancer 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 ...