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

Last updated: December 18, 2023
Sponsor: Erasme University Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Idiopathic Pulmonary Fibrosis

Cystic Fibrosis

Lung Injury

Treatment

FAPI PET/CT

Clinical Study ID

NCT06189820
P2022/587
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults patients with a fibrotic lung disease (idiopathic pulmonary fibrosis (IPF) ornon-IPF fibrotic ILD) as defined according to the 2022 ATS/ERS/JRS/ALAT ClinicalPractice Guidelines

Exclusion

Exclusion Criteria:

  • Pregnant or nursing patients
  • Patients with another significant medical condition which, in the investigator'sopinion, may interfere with the completion of the study.
  • Patients with an active lung neoplasm or any active neoplasm for blood samples

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: FAPI PET/CT
Phase: 2
Study Start date:
March 09, 2023
Estimated Completion Date:
March 09, 2027

Study 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).

Connect with a study center

  • Medecine

    Brussels, 1070
    Belgium

    Active - Recruiting

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