Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasme University Hospital
About this trial
To evaluate the effect of an anti-fibrotic treatment initiation on the fibrotic activity as assessed by FAPI PET/CT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults patients with a fibrotic lung disease (idiopathic pulmonary fibrosis (IPF) or non-IPF fibrotic ILD) as defined according to the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guidelines
Disqualifiers
Pregnant or nursing patients
Patients with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.
Patients with an active lung neoplasm or any active neoplasm for blood samples
Trial design
Design model
Single group
Treatments tested in this trial
FAPI PET/CT
Diagnostic testIn the department of Nuclear Medicine: * Installation in a relax chair after weight and height control * Placement of a venous line in the upper limb after which an infusion of 500ml of 0.9% NaCl is started. * Intravenous injection of 3 MBq/kg (max 300 MBq) of 18F- FAPI 74 or of 2 MBq/kg 68Ga-FAPI46
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
FAPI uptake on PET/CT
Decrease in lung FAPI uptake after the initiation of treatment, measured with the following PET parameters: SUVmax, SUVmean and Total lesion fapi uptake (TLA) in the lungs of the patients
Time frame
From date of inclusion till date of the second FAPI PET/CT (after 3 months)Secondary outcomes
1
Correlation between lung FAP expression and clinical evolution
Correlation between lung FAP expression (as assessed on blood/BAL or on FAPI PET/CT) and the clinical evolution based on the analysis of the slope of FVC decreased, absolute and relative changes in FVC at 12 months, time to progression/death or lung transplantation, time to first acute exacerbation
Time frame
From date of inclusion for a period of 2 years2
Comparison of different FAPi tracers
Comparison of PET parameters on 68Ga-FAPI and 18F-FAPI images (SUVmax, SUVmean) in lungs
Time frame
From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks)3
Comparison of different FAPi tracers
Comparison of PET parameters of 68Ga-FAPI and 18F-FAPI images (SUVmax, SUVmean) in blood pool
Time frame
From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks)4
Correlation between lung FAPI uptake and corresponding FAP assessment in blood and BAL samples.
Correlation between lung FAPI uptake on the PET images (SUVmean, SUVmax, TLA) and corresponding quantitative FAP assessment in blood and BAL samples.
Time frame
From date of inclusion till last BAL sample taken, up to a maximum period of 2 years follow-upSponsors and contacts
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Source ClinicalTrials.gov