Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Share Trial

Download Trial

Is this your trial?

If this is your trial and you’d like to update the information or upload supporting documentation, please contact Ancora.ai

Download Trial

Source: NCT06738680

Not yet recruiting

PROFIL-1: 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

Lung Cancer

Phase not listed

Multi-Site Study

France

Sponsor: University Hospital, Brest

Last Updated: March 25, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

Show Detailed Description

Study Type

Diagnostic

Radiation

Positron

Radiopharmaceutical

F-18 Fludeoxyglucose

Target

Glucose metabolism

Trial Started

January 30, 2025

Last Updated by Sponsor

March 25, 2025

Estimated Completion

January 30, 2026

Eligibility

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

Design Details

AllocationN/A

Intervention ModelN/A

MaskingN/A

Number to Enroll120

Arms & Interventions

Arms

Interventions

No interventions available.

Outcome Measures

Primary Outcome Measures

1-year Progression-Free SurvivalFrom 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.

Secondary Outcome Measures

Measurement of Ki imagesFrom baseline PET/CT before chemo immunotherapy in ml/min/100 g

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

Measurement of distribution volumeFrom baseline PET/CT before chemo immunotherapy in L/kg

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

Correlation between quantitative dynamic and radiomic parameters and clinico-histopathological parametersFrom baseline PET/CT before chemo immunotherapy

Correlation analyses between quantitative dynamic and radiomic PET derived parameters and clinico-histopathological parameters (clinical, biology, histology, genomic).

Contrast-to-noise ratio (CNR)From baseline LAFOV PET/CT

Contrast-to-noise ratio (CNR) (indicating the image quality in the lesion)

Target-to-background ratio (TBR)From baseline LAFOV PET/CT

Target-to-background ratio (TBR), defined as the ratio of the lesions&#39; SUVmax and the SUVmean of healthy liver tissue (background) determined for each reconstruction algorithm

Objective response rate (ORR)From baseline LAFOV PET to end of 1 year of treatment

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

Metabolic response rate (MRR)From baseline LAFOV PET to end of 1 year of treatment

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)

Overall SurvivalFrom date of chemo-immunotherapy initiation until the date of death from any cause, assessed up to 100 months

Overall Survival, defined as the time from chemo-immunotherapy initiation until the date of death from any cause, assessed up to 100 months

SafetyFrom baseline LAFOV PET to end of 1 year of treatment

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).

Trial Sites

This study has 2 trial sites

Brest University Hospital
Brest, FR

N/A

Brest, 29609 FR

Brest University Hospital

N/A

Morlaix, 29600 FR

Morlaix Hospital Center

Loading Maps...