Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases (FAPIPET)

F

Free University of Brussels (ULB)

Status and phase

Enrolling
Phase 2

Conditions

Pulmonary Fibrosis
FAP
Idiopathic Pulmonary Fibrosis
Lung Fibrosis

Treatments

Diagnostic Test: FAPI PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT06189820
P2022/587

Details and patient eligibility

About

To evaluate the effect of an anti-fibrotic treatment initiation on the fibrotic activity as assessed by FAPI PET/CT.

Full 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).

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

Trial contacts and locations

1

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Central trial contact

Benjamin Bondue

Data sourced from clinicaltrials.gov

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