NCT06189820

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pulmonary Fibrosis
• Lung Fibrosis
• Idiopathic Pulmonary Fibrosis
• FAP

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-09
• Primary completion: 2027-03-09
• Completion: 2027-03-09
• First posted: 2024-01-05
• Last updated: 2024-01-05

Locations

1 site across 1 country: Belgium