[18F]-AraG PET Imaging in LA HNSCC

Официальное название

[18F]-AraG PET Imaging for Enhanced Risk Stratification and Chemoradiotherapy Response Assessment in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат [18F]-AraG radiotracer
  \[18F\]-AraG radiotracer, which occurs on the first and sixteenth day of treatment.
• Препарат Chemotherapy
  Concurrent chemoradiotherapy (CRT) with weekly doses of cisplatin.
• Устройство Radiotherapy
  Concurrent chemoradiotherapy (CRT) of 70Gy of radiation dose in 33 fractions.

Первичные конечные точки

• [18F]-AraG PET/CT uptake and infiltrating cytotoxic T-cell expression. [Срок оценки: Week 1 and Week 16]
• Pre-treatment [18F]-AraG PET/CT uptake and clinical response. [Срок оценки: Pre-treatment]
• Changes between pre-treatment and mid-treatment [18F]-AraG PET/CT uptake and clinical response [Срок оценки: Pre-treatment and Week 16]

Вторичные конечные точки (3)

• Individual cytotoxic T-cell activities (CD3+, CD8+, PD1-, and PD1+) and pre-treatment [18F]-AraG PET/CT uptake [Срок оценки: Pre-Treatment]
• Tumor extent and standard uptake values between FDG PET and [18F]-AraG PET/CT imaging [Срок оценки: treatment planning through post treatment ( up to 6 months)]
• [18F]-AraG PET/CT uptake over time and progressive-free survival [Срок оценки: up to 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Indiana University — Indianapolis

Идентификаторы

NCT: NCT07168785 · CTO-IUSCCC-0910

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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