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Lung cancer is the leading cause of cancer deaths worldwide. Revolution of chemo-immunotherapy (CT-IO) in first-line of metastatic non-small-cell lung cancers (NSCLC) without actionable genomic alterations (AGAs) has dramatically improved prognosis, providing long response to a subset of patients. Because of a highly heterogeneous disease, majority of patients do not show long term benefit. Long axial field of view positron emission tomography (LAFOV-PET) scanner is a new emerging system allowing dynamic whole-body imaging with higher sensitivity, representing unique opportunity for oncological applications. The aim of this study is to determine if LAFOV-PET imaging biomarkers could early predict response to CT-IO in NSCLC.
Lung cancer is the leading cause of cancer deaths worldwide. Revolution of chemo-immunotherapy (CT-IO) in first-line of metastatic non-small-cell lung cancers (NSCLC) without actionable genomic alterations (AGAs) has dramatically improved prognosis, providing long response to a subset of patients. Because of a highly heterogeneous disease, majority of patients do not show long term benefit. Long axial field of view positron emission tomography (LAFOV-PET) scanner is a new emerging system allowing dynamic whole-body imaging with higher sensitivity, representing unique opportunity for oncological applications. The aim of this study is to determine if LAFOV-PET imaging biomarkers could early predict response to CT-IO in NSCLC.
PROFIL-1 is a multicentre, single-arm, prospective non-interventional pilot study investigating the predictive value of multiparametric 18F-fluoro-deoxyglucose whole-body dynamic PET imaging on a LAFOV system for first-line CT-IO efficacy in advanced NSCLC, with a planned enrolment of 120 patients at 2 French sites. Adult patients with treatment-naïve advanced non-squamous or squamous NSCLC without AGAs and eligible for first-line CT-IO will be recruited for PROFIL-1. Patients will undergo LAFOV-PET before and after CT-IO induction. The primary objective is to evaluate predictive performance of a whole-body multiparametric analysis (radiomics and dynamics) in LAFOV-PET on CT-IO efficacy based on progression-free survival (PFS) per RECIST v1.1 by investigators. Secondary endpoints included correlations between imaging parameters and clinico-pathological characteristics, comparison between direct Patlak and indirect Patlak methods to determine dynamic parameters such as Ki (the net influx rate) and distribution volume (DV), number of tumor lesions and signal-to-noise ratio, objective response rate (ORR), overall survival (OS) and safety.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAFOV system (an innovative, latest-generation system) scan | Diagnostic Test | To collect data from the LAFOV system (an innovative, latest-generation system) during the PET scan planned as part of your treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year Progression-Free Survival | The primary endpoint is 1-year Progression-Free Survival (PFS) rate. PFS is defined as the time from chemo-immunotherapy initiation to the date of the first documented event of tumor progression or death in the absence of disease progression, whichever came first, assessed up to 100 months. | From date of chemo-immunotherapy initiation until the date of first documented progression or date of death, assessed up to 100 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Ki images | Measurement of Ki images PET/CT parameters based on direct and indirect Patlak reconstruction methods with PBIF or IDIF in LAFOV-PET from baseline PET/CT before chemo immunotherapy | From baseline PET/CT before chemo immunotherapy in ml/min/100 g |
| Measurement of distribution volume |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with unresectable locally advanced non-irradiable or metastatic NSCLC, whose files are presented to the thoracic oncology Multidisciplinary Team at the Brest University Hospital and the Morlaix University Hospital, and for whom chemo-immunotherapy is indicated as 1st line treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margaux GEIER | Contact | +33230338030 | margaux.geier@chu-brest.fr | |
| Ronan ABGRAL | Contact | +33298223069 | ronan.abgral@chu-brest.fr |
| Name | Affiliation | Role |
|---|---|---|
| Margaux GEIER | University Hospital, Brest | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brest University Hospital | Brest | 29609 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41931499 | Derived | Geier M, Amrane K, Bourhis D, Le Roux PY, Nguyen J, Dhamelincourt E, Descourt R, Quere G, Guegan M, Besse B, Deandreis D, Besson F, Faure S, Karakatsanis N, Salaun PY, Pavoine M, Bourbonne V, Lucia F, Abgral R. PRognostic and predictive potential Of multiparametric dynamic whole-body 18F-FDG PET Imaging using a Long axial field-of-view (LAFOV) system for FIRST-line chemo-immunotherapy efficacy in advanced non-small cell lung cancer: PROFIL-1 study protocol. PLoS One. 2026 Apr 3;21(4):e0345990. doi: 10.1371/journal.pone.0345990. eCollection 2026. |
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Measurement of distribution volume dynamic PET/CT parameter based on direct and indirect Patlak reconstruction methods with PBIF or IDIF in LAFOV-PET from baseline PET/CT before chemo immunotherapy |
| From baseline PET/CT before chemo immunotherapy in L/kg |
| Correlation between quantitative dynamic and radiomic parameters and clinico-histopathological parameters | Correlation analyses between quantitative dynamic and radiomic PET derived parameters and clinico-histopathological parameters (clinical, biology, histology, genomic). | From baseline PET/CT before chemo immunotherapy |
| Contrast-to-noise ratio (CNR) | Contrast-to-noise ratio (CNR) (indicating the image quality in the lesion) | From baseline LAFOV PET/CT |
| Target-to-background ratio (TBR) | Target-to-background ratio (TBR), defined as the ratio of the lesions' SUVmax and the SUVmean of healthy liver tissue (background) determined for each reconstruction algorithm | From baseline LAFOV PET/CT |
| Objective response rate (ORR) | Objective response rate (ORR), defined as the proportion of patients experiencing an objective response (either complete response [CR] or partial response [PR]) as best response to CT-IO according to RECIST 1.1 criteria | From baseline LAFOV PET to end of 1 year of treatment |
| Metabolic response rate (MRR) | Metabolic response rate (MRR), defined as the proportion of patients experiencing a metabolic response (either complete metabolic response [CMR] or partial metabolic response [PMR]) as best response to CT-IO according to Positron Emission Tomography Response Criteria in Solid Tumors version 1.0 (PERCIST v1.0) | From baseline LAFOV PET to end of 1 year of treatment |
| Overall Survival | Overall Survival, defined as the time from chemo-immunotherapy initiation until the date of death from any cause, assessed up to 100 months | From date of chemo-immunotherapy initiation until the date of death from any cause, assessed up to 100 months |
| Safety | Safety and tolerability according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.; Patient reported outcomes according to EQ-5D-5L and EORTC QLQ-C30 (baseline, 3 months, 6 months, 12 months). | From baseline LAFOV PET to end of 1 year of treatment |
| Morlaix Hospital Center | Morlaix | 29600 | France |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011877 | Radionuclide Imaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003947 | Diagnostic Techniques, Radioisotope |
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