Trials / Not Yet Recruiting
Not Yet RecruitingNCT07168785
[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
- Status
- Not Yet Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- Sponsor
- Indiana University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-10-01
- Primary completion
- 2027-06-01
- Completion
- 2027-10-01
- First posted
- 2025-09-11
- Last updated
- 2025-09-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07168785. Inclusion in this directory is not an endorsement.