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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001489-40 | EudraCT Number |
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[18F]F-AraG is a promising tracer to image activated T-cells with positron emission tomography (PET). The aim of the ATTAIN trial is to investigate the pharmacokinetic characteristics of this novel tracer by performing a full kinetic modelling, assess test-retest (TRT) variability and to correlate the tumor tracer uptake with the pathological assessment.
The efficacy of immunotherapy and patient selection for combinatorial immunotherapy strategies would greatly improve if the tumor microenvironment (TME) could be characterized more accurately. Positron emission tomography (PET) using tracers that target immune cell subsets may provide a non-invasive means to immune profile the TME. Imaging T-cells can help in identifying 'hot' tumors, or parts of the tumor mass that have high concentrations of tumor infiltrating T-cells and also provide information on its activation.
A promising tracer to image activated T-cells is [18F]F-AraG. Based on the hypothesis that [18F]F-AraG will accumulate in activated T-cells, it is expected that [18F]F-AraG and PET will enable to (reproducibly) identify tumors and tumor areas with high concentrations of tumor infiltrating activated T-cells on pathological assessment. In the ATTAIN trial this [18F]F-AraG uptake in tumor lesions and healthy organs is explored by full kinetic modelling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]F-AraG PET procedures | Experimental | Within one week prior to resection two [18F]F-AraG PET-scans will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]F-AraG PET-scan | Diagnostic Test | [18F]F-AraG PET scans are performed to assess the accumulation of activated T-cells in the tumour and healthy tissue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Full kinetic modelling | To perform full kinetic modeling of [18F]F-AraG for the uptake in tumor lesions and healthy organs (e.g. spleen) by exploring different kinetic models and outcome measures as well as its test-retest (TRT) variability to guide the selection of an optimal PET pharmacokinetic model. | six months |
| Correlation with number of CD8 T-cell | To correlate the relationship between the tumor uptake of [18F]F-AraG and the number of CD8 T-cells amongst others as measured by Immunohistochemistry (IHC) and gene expression. | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation with [18F]-FDG PET uptake | To correlate the [18F]-FDG PET uptake with uptake derived from [18F]F-AraG PET | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation with immune profile of PBMCs | To explore the [18F]F-AraG PET uptake in tumor, lymph nodes and spleen with the immune profile of peripheral blood mononuclear cells (PBMC). | one year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| I. Bahce, MD, PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC, location VU University Medical Center | Amsterdam | Nederland | 1081HV | Netherlands |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |