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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 1-year Progression-Free Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
1-year Progression-Free Survival
时间窗: From date of chemo-immunotherapy initiation until the date of first documented progression or date of death, assessed up to 100 months.
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.
次要结局
- Measurement of Ki images(From baseline PET/CT before chemo immunotherapy in ml/min/100 g)
- Measurement of distribution volume(From baseline PET/CT before chemo immunotherapy in L/kg)
- Correlation between quantitative dynamic and radiomic parameters and clinico-histopathological parameters(From baseline PET/CT before chemo immunotherapy)
- Contrast-to-noise ratio (CNR)(From baseline LAFOV PET/CT)
- Target-to-background ratio (TBR)(From baseline LAFOV PET/CT)
- Objective response rate (ORR)(From baseline LAFOV PET to end of 1 year of treatment)
- Metabolic response rate (MRR)(From baseline LAFOV PET to end of 1 year of treatment)
- Overall Survival(From date of chemo-immunotherapy initiation until the date of death from any cause, assessed up to 100 months)
- Safety(From baseline LAFOV PET to end of 1 year of treatment)