Clinical trial NCT06189820: Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases
Official title: Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pulmonary Fibrosis
Lung Fibrosis
Idiopathic Pulmonary Fibrosis
FAP
Keywords: Pulmonary fibrosis
FAP
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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

Primary outcomes:
measure: FAPI uptake on PET/CT
timeFrame: From date of inclusion till date of the second FAPI PET/CT (after 3 months)
Secondary outcomes:
measure: Correlation between lung FAP expression and clinical evolution
timeFrame: From date of inclusion for a period of 2 years
measure: Comparison of different FAPi tracers
timeFrame: From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks)
measure: Comparison of different FAPi tracers
timeFrame: From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks)
measure: Correlation between lung FAPI uptake and corresponding FAP assessment in blood and BAL samples.
timeFrame: From date of inclusion till last BAL sample taken, up to a maximum period of 2 years follow-up
measure: Correlation between lung FAPI uptake and immunohistological evaluation of the FAP expression on lung samples (after lung transplantation, surgical lung biopsy or cryobiopsy)
timeFrame: From date of inclusion until surgery, for a maximum period of 2 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Medecine
Study officials:
References: