FAP, Idiopathic Pulmonary Fibrosis, Lung Fibrosis, Pulmonary Fibrosis
Conditions
Keywords
Pulmonary fibrosis, FAP
Brief summary
To evaluate the effect of an anti-fibrotic treatment initiation on the fibrotic activity as assessed by FAPI PET/CT.
Detailed description
To evaluate the use of the fibroblast activation protein (FAP) as a biomarker of fibrotic lung disease (idiopathic pulmonary fibrosis (IPF) and non-IPF ILDs). The study will include both analysis of FAP expression in samples stored in the biobank of the department of Pneumology (BAL, blood, induced sputum and EBC) (cohort A) and lung FAPI uptake on PET/CT scans performed at the department of Nuclear Medicine: * before and after the initiation of an antifibrotic therapy (IPF or PPF) (cohort B) * before and after the initiation of corticosteroid therapy in case of an acute exacerbation of ILD (cohort C) * before and after the initiation of an immunosuppressive drug in the context of non-IPF pulmonary fibrosis (cohort D). * before lung transplantation, surgery or biopsy to correlate with FAP expression determined by immunohistochemical analysis (IHC) (cohort E).
Interventions
DIAGNOSTIC_TESTFAPI PET/CT
In 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
Sponsors
Erasme University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FAPI uptake on PET/CT | From date of inclusion till date of the second FAPI PET/CT (after 3 months) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between lung FAP expression and clinical evolution | From date of inclusion for a period of 2 years | 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 |
| Comparison of different FAPi tracers | From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks) | Comparison of PET parameters on 68Ga-FAPI and 18F-FAPI images (SUVmax, SUVmean) in lungs |
| Correlation between lung FAPI uptake and corresponding FAP assessment in blood and BAL samples. | From date of inclusion till last BAL sample taken, up to a maximum period of 2 years follow-up | Correlation between lung FAPI uptake on the PET images (SUVmean, SUVmax, TLA) and corresponding quantitative FAP assessment in blood and BAL samples. |
| Correlation between lung FAPI uptake and immunohistological evaluation of the FAP expression on lung samples (after lung transplantation, surgical lung biopsy or cryobiopsy) | From date of inclusion until surgery, for a maximum period of 2 years | Correlation between lung FAPI uptake on the PET images (SUVmean, SUVmax, TLA) and immunohistological evaluation of the FAP expression on lung samples (after lung transplantation, surgical lung biopsy or cryobiopsy) |
Countries
Belgium
Contacts
Primary ContactBenjamin Bondue
Outcome results
None listed