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

December 18, 2023 updated by: Erasme University Hospital
To evaluate the effect of an anti-fibrotic treatment initiation on the fibrotic activity as assessed by FAPI PET/CT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of inclusion till date of the second FAPI PET/CT (after 3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of inclusion for a period of 2 years
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
From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks)
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
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.
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.
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)
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)
From date of inclusion until surgery, for a maximum period of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2023

Primary Completion (Estimated)

March 9, 2027

Study Completion (Estimated)

March 9, 2027

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

December 18, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2022/587

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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