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Not yet recruiting NCT07168785

[18F]-AraG PET Imaging in LA HNSCC

Early Phase I Interventional Head and Neck Squamous Cell Carcinoma (HNSCC) Locally Advanced Head and Neck Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [18F]-AraG radiotracer, Chemotherapy, Radiotherapy.
Who it may be relevant to
Registry conditions: Head and Neck Squamous Cell Carcinoma (HNSCC), Locally Advanced Head and Neck Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.
  • Drug Chemotherapy
    Concurrent chemoradiotherapy (CRT) with weekly doses of cisplatin.
  • Device Radiotherapy
    Concurrent chemoradiotherapy (CRT) of 70Gy of radiation dose in 33 fractions.

Primary outcome measures

  • [18F]-AraG PET/CT uptake and infiltrating cytotoxic T-cell expression. [Time frame: Week 1 and Week 16]
  • Pre-treatment [18F]-AraG PET/CT uptake and clinical response. [Time frame: Pre-treatment]
  • Changes between pre-treatment and mid-treatment [18F]-AraG PET/CT uptake and clinical response [Time frame: Pre-treatment and Week 16]
Secondary outcome measures (3)
  • Individual cytotoxic T-cell activities (CD3+, CD8+, PD1-, and PD1+) and pre-treatment [18F]-AraG PET/CT uptake [Time frame: Pre-Treatment]
  • Tumor extent and standard uptake values between FDG PET and [18F]-AraG PET/CT imaging [Time frame: treatment planning through post treatment ( up to 6 months)]
  • [18F]-AraG PET/CT uptake over time and progressive-free survival [Time frame: up to 6 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Indiana University — Indianapolis

Identifiers

NCT: NCT07168785 · CTO-IUSCCC-0910

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗