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.
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).
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.
Single group
[18F]-AraG radiotracer
Drug\[18F\]-AraG radiotracer, which occurs on the first and sixteenth day of treatment.
Chemotherapy
DrugConcurrent chemoradiotherapy (CRT) with weekly doses of cisplatin.
Radiotherapy
DeviceConcurrent chemoradiotherapy (CRT) of 70Gy of radiation dose in 33 fractions.
[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
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.
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.
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.
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.
[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.
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Indiana University
Lead sponsor
CellSight Technologies, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
