Clinical trial · Interventional
[18F]-AraG PET Imaging in LA HNSCC
[18F]-AraG PET Imaging for Enhanced Risk Stratification and Chemoradiotherapy Response Assessment in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT07168785CI-TRIAL-00118902not yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma (HNSCC) | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Locally Advanced Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]-AraG radiotracer | Drug | — | UNRESOLVED |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Radiotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]-AraG PET/CT scan
- description
- \[18F\]-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.
- interventionNames
- Drug: [18F]-AraG radiotracer
- Drug: Chemotherapy
- Device: Radiotherapy
Primary outcomes (3)
- measure
- [18F]-AraG PET/CT uptake and infiltrating cytotoxic T-cell expression.
- timeFrame
- Week 1 and Week 16
- description
- Examining the distribution of \[18F\]-AraG PET SUV metrics and counts of CD3+/CD8+/PD1- and CD3+/CD8+/PD1+ T-cells
- measure
- Pre-treatment [18F]-AraG PET/CT uptake and clinical response.
- timeFrame
- Pre-treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.