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

NCT06189820 | Recruiting Phase 2

• 1 other identifier: P2022/587
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Fibrosis; Lung Fibrosis; Idiopathic Pulmonary Fibrosis; FAP

Keywords

Pulmonary fibrosis; FAP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Correlation between lung FAP expression and clinical evolution

  From date of inclusion for a period of 2 years

• Comparison of different FAPi tracers

  From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks)

• Comparison of different FAPi tracers

  From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks)

• Correlation between lung FAPI uptake and corresponding 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

• Correlation between lung FAPI uptake 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

Interventions

FAPI PET/CT DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Medecine

Brussels, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Benjamin Bondue

CONTACT

+ 32 (2) 555 5758; benjamin.bondue@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: January 5, 2024
• Study Start: March 9, 2023
• Primary Completion (Estimated): March 9, 2027
• Study Completion (Estimated): March 9, 2027
• Last Updated: January 5, 2024

Record last verified: 2023-11

Locations

BE (1)