Clinical trial · Interventional
Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG
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
Summary
Brief summary (as posted)
This pilot study uses \[18F\]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors. The study's main objectives are to quantify the change in \[18F\]F AraG PET signal before and while on CkIT therapy and to correlate this change in \[18F\]F AraG PET signal with radiographic response. To explore these objectives, eligible subjects will undergo pre- and on - CkIT treatment \[18F\]F AraG PET/CT scans, and will be followed up for 12 months for assessment of radiographic and clinical outcomes. This study is a single-site, open label, non randomized, single arm pilot trial. Patients and care providers will not be blinded to any part of the study.
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 |
|---|---|---|---|
| Advanced Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]F-AraG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Advanced non small cell lung cancer (NSCLC) patients undergoing PD-1/PD-L1 directed therapy
- interventionNames
- Drug: [18F]F-AraG
Primary outcomes (2)
- measure
- [18F]F-AraG Quantification
- timeFrame
- One Year
- description
- Quantitative assessment of tracer uptake by Standardized Uptake Value (SUV) based measurements within volumes of interest on pre- and on-treatment \[18F\]F AraG PET scans compared.
- measure
- [18F]F AraG Correlation
- timeFrame
- One Year
- description
- Comparison of quantitative change in tracer uptake between pre- and on-treatment with radiographic outcomes as defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) \> 4 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease. 2. Measurable disease. 3. ECOG performance status of 0, 1 or 2. 4. Subjects are willing to be followed at the University of Iowa. Exclusion Criteria: 1. Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives. 2. Pregnant women or nursing mothers. 3. Patients with severe claustrophobia.
References
Publications (0)
Data not yet available