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Evaluation of the relation between baseline fibroblast activation protein (FAP) expression based on Ga-FAPI uptake with patient outcome among NSCLC patients receiving immunotherapy for recurrent/metastatic disease.
Fibroblast activation protein (FAP), a type II membrane glycoprotein, is selectively expressed by cancer-associated fibroblasts (CAFs) in more than 90% of epithelial carcinomas. FAP also regulates antitumor immune response. For these reasons, FAP is an attractive target and molecular imaging biomarker to assess CAFs and the tumour's landscape before and during immunotherapy. The PET radiotracer 68Ga-FAPI (Fibroblast activation protein inhibitor) allows the visualisation and quantification of CAFs.This study will use a non-invasive technique to assess CAFs before and during immunotherapy and to evaluate diverse predictive biomarkers in a prospective setting studying simultaneously CAFs (using 68Ga-FAPI) and cfDNA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAPI PET/CT | Experimental | The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is injected intravenously for molecular imaging of FAP expression with FAPI PET/CT in patients with NSCLC with an indication for immunotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAPI PET/CT | Procedure | The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is injected intravenously for molecular imaging of FAP expression with FAPI PET/CT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Patient outcome assessed by progression-free survival (PFS) defined as the time from the start of immunotherapy until disease progression* or death by any cause during the period of active and routine follow-up (overall PFS) | From date of inclusion until the date of first documented progression (RECIST) or date of death from any cause, whichever came first, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Patient outcome assessed by 0verall survival (OS) defined as the time from the start of immunotherapy until death by any cause. | until death by any cause, assessed up to 24 months |
| Objective response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Recruiting | Brussels | 1070 | Belgium |
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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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molecular imaging of FAP
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Patient outcome assessed by objective response rate based on iRECIST criteria
• Kinetics of imaging biomarkers assessed with 68Ga-FAPI PET/CT at baseline and during treatment - examples of kinetics of imaging biomarkers: ΔSUVmax / ΔSUVpeak / ΔUptake-Volume.
| From date of inclusion until the date of first documented progression (RECIST) or date of death from any cause, whichever came first, assessed up to 24 months |
| cfDNA | Kinetics of cfDNA values at baseline and during treatment | From date of inclusion until the date of last FAPI PET/CT (6 weeks after start immunotherapy) |
| Number of lesions | Number of metastatic lesions and the imaging biomarkers (SUVmax / SUVpeak / Uptake-Volume / Tumour-to-Background ratio) of the lesions on 68Ga-FAPI PET/CT and 18F-FDG PET/CT | From date of inclusion until the date of first documented progression (RECIST) or date of death from any cause, whichever came first, assessed up to 24 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |