Clinical trial · Interventional
PET Imaging With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC)
A Study of PET Imaging of T-cell Activation With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1-directed Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study is terminated because the PI left the institution.
Summary
Brief summary (as posted)
This is a prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called \[18F\]F-AraG is a helpful imaging agent for detecting changes in cancer's anti-tumor immune response (or activation of T-cell) levels for non-small cell lung cancer (NSCLC) patients who will receive a cancer immunotherapy regimen (immunotherapy works by encouraging the body's own immune system to attack the cancer cells).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]F-AraG Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]F-AraG
- description
- A one-time nominal injection dose of 5 millicurie (mCi) +/- will be administered at each PET/CT imaging time point.
- interventionNames
- Drug: [18F]F-AraG Injection
Primary outcomes (3)
- measure
- Percent Change in uptake of [18F]F-AraG before and after one dose of anti-PD-L1
- timeFrame
- Baseline and 10-14 days after first dose of neoadjuvant therapy
- description
- Percent Change in standard uptake value (SUV) of \[18F\]F-AraG PET-CT imaging of primary tumor and of lymph nodes at baseline to after the first dose of neoadjuvant therapy.
- measure
- Percent pathologic response at the time of surgery
- timeFrame
- At the time of surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older and willing and able to provide informed consent. * Subjects with stage I, II, or III A NSCLC and plan to receive neoadjuvant PD-1/PD-L1 immunotherapy with an intention for curative surgery. Subjects will be receiving neoadjuvant immunotherapy through enrollment in therapeutic clinical trials * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at the time of enrollment. * For females of childbearing potential, negative serum pregnancy test within a 10 day period will be obtained prior to PET study. Exclusion Criteria: * Severe impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73 m2 and/or on dialysis. * Pregnant female patients; breastfeeding female patients. * Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject. * Any investigational radiation exposure in the past calendar year that in combination with the radiation exposure from this study would exceed 5 rem. * Administered a radioisotope ≤5 physical half-lives prior to the day of PET/CT.
References
Publications (0)
Data not yet available