Clinical trial · Interventional
Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer
- 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)
The iRelate is a PET imaging trial to compare two upcoming and promising T cell PET tracers. Following chemo-immuno therapy, as part of standard care, NSCLC patients will be recruited to receive two PET scans, shortly before their surgery. Both PET scans will be compared to each other, as well as compared to the pathological analysis of the resected tumor. This study will provide detailed information on the unique as well as additive capacities of imaging biomarkers derived from the immune cell targeting PET tracers.
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 |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]F-AraG PET imaging | Drug | — | UNRESOLVED |
| [89Zr]Zr-Df-Crefmirlimab PET imaging | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dual T cell PET imaging
- description
- Patients will receive PET imaging with two different T-cell targeting tracers.
- interventionNames
- Drug: [18F]F-AraG PET imaging
- Drug: [89Zr]Zr-Df-Crefmirlimab PET imaging
Primary outcomes (2)
- measure
- To measure the spatial correlation of PET uptake of [18F]F-AraG and [89Zr]Zr-Df-Crefmirlimab in tumors and T-cell rich organs such as lymph nodes prior to resection.
- timeFrame
- 2 months
- description
- The spatial overlap of the regions of uptake for both PET tracers will be assessed using the Dice Similarity Coefficient (DSC) as an established method
- measure
- To measure the strength of correlation between the presence of CD8+ cells and T cell activation features in the resected tumor and lymph nodes with preoperative uptake of [89Zr]Zr-Df-Crefmirlimab and [18F]F-AraG, respectively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed NSCLC * T1-4N0-2, lesion size of ≥2cm, at time of the restaging FDG PET/CT * Planned to undergo resection after chemo-IO according to routine treatment guidelines * Willing and able to provide written informed consent for the trial * Above 18 years of age on day of signing informed consent * Have measurable disease based on RECIST 1.1 * Have a ECOG performance status of 0-1, and are considered operable based on pulmonary function test and/or exercise testing Exclusion Criteria: * Patients deemed inoperable * Patients who have received a splenectomy * Patients who have received any vaccination within 14 days of enrollment * Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid \>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. * Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial.
References
Publications (0)
Data not yet available