[18F]-AraG PET Imaging for Enhanced Risk Stratification and Chemoradiotherapy Response Assessment in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- [18F]-AraG PET/CT uptake and infiltrating cytotoxic T-cell expression.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
- •Unresectable cases.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Willing and able to maintain the imaging protocol.
- •Patients planning to receive pre-CRT and post-CRT FDG PET/CT scans as part of the standard clinical practice.
排除标准
- •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.
研究组 & 干预措施
[18F]-AraG PET/CT scan
[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.
干预措施: [18F]-AraG radiotracer (Drug)
[18F]-AraG PET/CT scan
[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.
干预措施: Chemotherapy (Drug)
[18F]-AraG PET/CT scan
[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.
干预措施: Radiotherapy (Device)
结局指标
主要结局
[18F]-AraG PET/CT uptake and infiltrating cytotoxic T-cell expression.
时间窗: 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.
时间窗: 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
时间窗: 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.
次要结局
- Individual cytotoxic T-cell activities (CD3+, CD8+, PD1-, and PD1+) and pre-treatment [18F]-AraG PET/CT uptake(Pre-Treatment)
- Tumor extent and standard uptake values between FDG PET and [18F]-AraG PET/CT imaging(treatment planning through post treatment ( up to 6 months))
- [18F]-AraG PET/CT uptake over time and progressive-free survival(up to 6 months)
研究者
Richard Zellars
Professor of Clinical Radiation Oncology
Indiana University