PRedictive Value of Multiparametric Dynamic WB 18F-FDG-PET Imaging on a LAFOV System for FIRST-line Chemo-immunotherapy Efficacy in Advanced Non-small-cell Lung Cancer: PROFIL-1
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: LAFOV system (an innovative, latest-generation system) scan.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. 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
- France
- 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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Official title
PRedictive Value of Multiparametric Dynamic Whole-body 18F-FDG-PET Imaging on a LAFOV System for FIRST-line Chemo-immunotherapy Efficacy in Advanced Non-small-cell Lung Cancer: PROFIL-1 Study
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test LAFOV system (an innovative, latest-generation system) scan
To collect data from the LAFOV system (an innovative, latest-generation system) during the PET scan planned as part of your treatment.
Primary outcome measures
- 1-year Progression-Free Survival [Time frame: From date of chemo-immunotherapy initiation until the date of first documented progression or date of death, assessed up to 100 months.]
Secondary outcome measures (9)
- Measurement of Ki images [Time frame: From baseline PET/CT before chemo immunotherapy in ml/min/100 g]
- Measurement of distribution volume [Time frame: From baseline PET/CT before chemo immunotherapy in L/kg]
- Correlation between quantitative dynamic and radiomic parameters and clinico-histopathological parameters [Time frame: From baseline PET/CT before chemo immunotherapy]
- Contrast-to-noise ratio (CNR) [Time frame: From baseline LAFOV PET/CT]
- Target-to-background ratio (TBR) [Time frame: From baseline LAFOV PET/CT]
- Objective response rate (ORR) [Time frame: From baseline LAFOV PET to end of 1 year of treatment]
- Metabolic response rate (MRR) [Time frame: From baseline LAFOV PET to end of 1 year of treatment]
- Overall Survival [Time frame: From date of chemo-immunotherapy initiation until the date of death from any cause, assessed up to 100 months]
- Safety [Time frame: From baseline LAFOV PET to end of 1 year of treatment]
Eligibility criteria
Inclusion criteria
- Adult patients ≥ 18 years
- With advanced, non-operable, non-radiatable or metastatic NSCLC
- Treatment-naïve patients
- Eligible for first-line chemo-immunotherapy (anti-PD-1)
- Written Non-objection
- Eligible for LAFOV FDG-PET less than 21 days before initiation of treatment
Exclusion criteria
- Minor patients <18 years
- Oncogenic addiction targetable in 1st line: EGFR, ALK, ROS1, RET
- Pregnancy or breast-feeding
- Other histology than NSCLC
- Ineligible for first-line chemo-immunotherapy
- PET-FDG Scan contraindications
- Refusal to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 2 centers
- Brest University Hospital — Brest
- Morlaix Hospital Center — Morlaix
Publications
- 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 PMID 41931499
Identifiers
NCT: NCT06738680 · 29BRC24.0049