[18F]-AraG PET Imaging in LA HNSCC

Not Applicable

Not yet recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC); Locally Advanced Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: [18F]-AraG radiotracer; Drug: Chemotherapy; Device: Radiotherapy

• Registration Number: NCT07168785
• Lead Sponsor: Indiana University

Brief 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.

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 Timeline

• Study First Submitted: 2025-08-27
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-04
• Last Update Submitted: 2025-09-04
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11
• Study Start: 2025-10-01
• Primary Completion: 2027-06
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]-AraG PET/CT scan	[18F]-AraG radiotracer	\[18F\]-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.
[18F]-AraG PET/CT scan	Chemotherapy	\[18F\]-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.
[18F]-AraG PET/CT scan	Radiotherapy	\[18F\]-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.

Primary Outcome Measures

Name	Time	Method
[18F]-AraG PET/CT uptake and infiltrating cytotoxic T-cell expression.	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
Pre-treatment [18F]-AraG PET/CT uptake and clinical response.	Pre-treatment	Correlation of pre-treatment \[18F\]-AraG PET/CT metrics (such as SUVmax, mean and uptake volume) and clinical response.
Changes between pre-treatment and mid-treatment [18F]-AraG PET/CT uptake and clinical response	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.

Secondary Outcome Measures

Name	Time	Method
Individual cytotoxic T-cell activities (CD3+, CD8+, PD1-, and PD1+) and pre-treatment [18F]-AraG PET/CT uptake	Pre-Treatment	Correlation between individual cytotoxic T-cell activities (CD3+, CD8+, PD1-, and PD1+) and pre-treatment \[18F\]-AraG PET/CT uptake.
Tumor extent and standard uptake values between FDG PET and [18F]-AraG PET/CT imaging	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.
[18F]-AraG PET/CT uptake over time and progressive-free survival	up to 6 months	Association between the pattern of change in \[18F\]-AraG PET/CT uptake over time and progressive-free survival.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States