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
NCT ID: NCT06738680
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
120 participants
OBSERVATIONAL
2025-01-30
2026-11-02
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Principal Investigators
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Margaux GEIER
Role: STUDY_DIRECTOR
University Hospital, Brest
Locations
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Brest University Hospital
Brest, , France
Morlaix Hospital Center
Morlaix, , France
Countries
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Central Contacts
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Facility Contacts
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Margaux GEIER
Role: primary
Ronan ABGRAL
Role: backup
Ronan ABGRAL
Role: backup
Karim AMRANE
Role: primary
Karim AMRANE
Role: backup
Other Identifiers
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29BRC24.0049
Identifier Type: -
Identifier Source: org_study_id