Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FAPI PET/CT.
- Who it may be relevant to
- Registry conditions: Pulmonary Fibrosis, Lung Fibrosis, Idiopathic Pulmonary Fibrosis, FAP. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test FAPI 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
Primary outcome measures
- FAPI uptake on PET/CT [Time frame: From date of inclusion till date of the second FAPI PET/CT (after 3 months)]
Secondary outcome measures (5)
- Correlation between lung FAP expression and clinical evolution [Time frame: From date of inclusion for a period of 2 years]
- Comparison of different FAPi tracers [Time frame: From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks)]
- Comparison of different FAPi tracers [Time frame: From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks)]
- Correlation between lung FAPI uptake and corresponding 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-up]
- Correlation between lung FAPI uptake and immunohistological evaluation of the FAP expression on lung samples (after lung transplantation, surgical lung biopsy or cryobiopsy) [Time frame: From date of inclusion until surgery, for a maximum period of 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Belgium · 1 center
- Medecine — Brussels
Identifiers
NCT: NCT06189820 · P2022/587