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

NCT06738680 | Not Yet Recruiting

• 1 other identifier: 29BRC24.0049
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Chemo-immunotherapy; Non-Small Cell Lung Cancer; Metastatic; Imaging Biomarkers; Prediction of response

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (9)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

Brest University Hospital

Brest, 29609, France

Location

Morlaix Hospital Center

Morlaix, 29600, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

Radionuclide Imaging

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Study Officials

• Margaux GEIER

  University Hospital, Brest

  STUDY DIRECTOR

Central Study Contacts

Margaux GEIER

CONTACT

+33230338030; margaux.geier@chu-brest.fr

Ronan ABGRAL

CONTACT

+33298223069; ronan.abgral@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: December 18, 2024
• Study Start: January 30, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): November 2, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

FR (2)