Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT06189820
NCT06189820RecruitingPhase 2

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

Erasme University Hospital2 sites in 1 country70 target enrollmentStarted: March 9, 2023Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
70
Locations
2
Primary Endpoint
FAPI uptake on PET/CT
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
Single (Care Provider)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Correlation between lung FAP expression and clinical evolution(From date of inclusion for a period of 2 years)
  • 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)
  • Comparison of different FAPi tracers(From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks))

Investigators

Sponsor
Erasme University Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Recruiting
Phase 2
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer DetectionSarcomaPheochromocytoma/Paraganglioma (PPGL)Pancreatic Ductal AdenocarcinomaMesotheliomaOvarian CancerHepatocellular CarcinomaGastric CancerCholangiocarcinomaOvarian CancerHepatocellular CarcinomaGastric CancerBladder CancerBladder CancerCholangiocarcinoma
NCT06503146National Cancer Institute (NCI)320
Recruiting
Not Applicable
[18F]AlF-NOTA-FAPI-04 PET/CT in Inflammation and Fibrosis in Renal Diseases18F-FAPI PET/CT ExaminationRenal Puncture Biopsy
NCT05752097Sichuan Provincial People's Hospital30
Unknown
Not Applicable
68Ga-FAPI PET/CT in Pancreatic Ductal CarcinomaPDAC
NCT05275985Peking Union Medical College Hospital80
Recruiting
Unknown
Pilot study of fibroblast activation factor expression in recurrent/progressive pancreatic cancer and mesothelioma using [68Ga]Ga-Fibroblast Activation Protein Inhibitor (FAPI) -46 PET imaging.pancreatic cancer
ACTRN12623001078640Sir Charles Gairdner and Osborne Park Health Care Group30
Recruiting
Not Applicable
Evaluation of biomarkers indicating fibrotic activity in idiopathic pulmonary fibrosis and other diffuse parenchymal lung diseases.J84J43Other interstitial pulmonary diseasesEmphysema
DRKS00000017Abteilung für Pneumologie400