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

Idiopathic Pulmonary Fibrosis Clinical Trial

— FAPIPET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06189820
• Other study ID #: P2022/587
• Status: Recruiting
• Phase: Phase 2
• Start date: March 9, 2023
• Est. completion date: March 9, 2027

Study information

• Verified date: November 2023
• Source: Erasme University Hospital
• Contact: Benjamin Bondue
• Phone: + 32 (2) 555 5758
• Email: benjamin.bondue[@]hubruxelles.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 9, 2027
• Est. primary completion date: March 9, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Belgium	Medecine	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FAPI uptake on PET/CT	Decrease in lung FAPI uptake after the initiation of treatment, measured with the following PET parameters: SUVmax, SUVmean and Total lesion fapi uptake (TLA) in the lungs of the patients	From date of inclusion till date of the second FAPI PET/CT (after 3 months)
Secondary	Correlation between lung FAP expression and clinical evolution	Correlation between lung FAP expression (as assessed on blood/BAL or on FAPI PET/CT) and the clinical evolution based on the analysis of the slope of FVC decreased, absolute and relative changes in FVC at 12 months, time to progression/death or lung transplantation, time to first acute exacerbation	From date of inclusion for a period of 2 years
Secondary	Comparison of different FAPi tracers	Comparison of PET parameters on 68Ga-FAPI and 18F-FAPI images (SUVmax, SUVmean) in lungs	From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks)
Secondary	Comparison of different FAPi tracers	Comparison of PET parameters of 68Ga-FAPI and 18F-FAPI images (SUVmax, SUVmean) in blood pool	From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks)
Secondary	Correlation between lung FAPI uptake and corresponding FAP assessment in blood and BAL samples.	Correlation between lung FAPI uptake on the PET images (SUVmean, SUVmax, TLA) and corresponding quantitative FAP assessment in blood and BAL samples.	From date of inclusion till last BAL sample taken, up to a maximum period of 2 years follow-up
Secondary	Correlation between lung FAPI uptake and immunohistological evaluation of the FAP expression on lung samples (after lung transplantation, surgical lung biopsy or cryobiopsy)	Correlation between lung FAPI uptake on the PET images (SUVmean, SUVmax, TLA) and immunohistological evaluation of the FAP expression on lung samples (after lung transplantation, surgical lung biopsy or cryobiopsy)	From date of inclusion until surgery, for a maximum period of 2 years