[18F]-AraG PET Imaging in LA HNSCC

Indiana University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma (HNSCC)

Treatments: Device: Radiotherapy; Drug: Chemotherapy; Drug: [18F]-AraG radiotracer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07168785

CTO-IUSCCC-0910

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

[18F]-AraG PET/CT scan

Experimental group

Description:

\[18F\]-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.

Treatment:

Drug: [18F]-AraG radiotracer

Device: Radiotherapy

Drug: Chemotherapy