Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [18F]F-AraG PET imaging, [89Zr]Zr-Df-Crefmirlimab PET imaging.
- Who it may be relevant to
- Registry conditions: NSCLC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug [18F]F-AraG PET imaging
Patients will receive a static whole-body PET scan following a \[18F\]F-AraG injection. - Drug [89Zr]Zr-Df-Crefmirlimab PET imaging
Patients will receive a static whole-body PET scan following a \[89Zr\]Zr-Df-Crefmirlimab injection.
Primary outcome measures
- 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. [Time frame: 2 months]
- 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. [Time frame: 6 months]
Secondary outcome measures (1)
- To measure the strength of correlation of pathological response (i.e., the residual viable tumor cells percentage) in the resected tumor with preoperative uptake of [89Zr]Zr-Df-Crefmirlimab and [18F]F-AraG. [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Netherlands · 1 center
- Amsterdam UMC, location VUmc — Amsterdam
Identifiers
NCT: NCT06457789 · 2023-509486-20-00 · 2023-509486-20-00