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NCT Number: NCT06189820

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

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

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Key information

Conditions

Pulmonary Fibrosis FAP Fibrosis Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Lung Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. FAPI uptake on PET/CT

    Time frame: From date of inclusion till date of the second FAPI PET/CT (after 3 months)

    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

Secondary outcomes

  1. Correlation between lung FAP expression and clinical evolution

    Time frame: From date of inclusion for a period of 2 years

    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

  2. Comparison of different FAPi tracers

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

    Comparison of PET parameters on 68Ga-FAPI and 18F-FAPI images (SUVmax, SUVmean) in lungs

  3. Comparison of different FAPi tracers

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

    Comparison of PET parameters of 68Ga-FAPI and 18F-FAPI images (SUVmax, SUVmean) in blood pool

  4. Correlation between lung FAPI uptake and corresponding FAP assessment in blood and BAL samples.

    Time frame: From date of inclusion till last BAL sample taken, up to a maximum period of 2 years follow-up

    Correlation between lung FAPI uptake on the PET images (SUVmean, SUVmax, TLA) and corresponding quantitative FAP assessment in blood and BAL samples.

  5. Correlation between lung FAPI uptake and immunohistological evaluation of the FAP expression on lung samples (after lung transplantation, surgical lung biopsy or cryobiopsy)

    Time frame: From date of inclusion until surgery, for a maximum period of 2 years

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Bondue

CONTACT

[email protected]

+ 32 (2) 555 5758

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Acronym: FAPIPET

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 5, 2024
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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