Head and Neck Squamous Cell Carcinoma (HNSCC), Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
AraG PET/CT, Chemoradiotherapy, [18F]-AraG PET/CT
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.
Interventions
DRUG[18F]-AraG radiotracer
\[18F\]-AraG radiotracer, which occurs on the first and sixteenth day of treatment.
DRUGChemotherapy
Concurrent chemoradiotherapy (CRT) with weekly doses of cisplatin.
DEVICERadiotherapy
Concurrent chemoradiotherapy (CRT) of 70Gy of radiation dose in 33 fractions.
Sponsors
Indiana University
CellSight Technologies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTKathryn I Lauer
PRINCIPAL_INVESTIGATORRichard Zellars, MD
Indiana University Simon Comprehensive Cancer Center
Outcome results
None listed