Status:
NOT_YET_RECRUITING
[18F]-AraG PET Imaging in LA HNSCC
Lead Sponsor:
Indiana University
Collaborating Sponsors:
CellSight Technologies, Inc.
Conditions:
Head and Neck Squamous Cell Carcinoma (HNSCC)
Locally Advanced Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 o...
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 patient...
Eligibility Criteria
Inclusion
- 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 33 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.
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT07168785
Start Date
October 1 2025
End Date
October 1 2027
Last Update
September 11 2025
Active Locations (1)
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1
Indiana University
Indianapolis, Indiana, United States, 46202