Actively Recruiting
Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases
Led by Erasme University Hospital · Updated on 2024-01-05
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the role of the fibroblast activation protein (FAP) as a biomarker in fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF) and other non-IPF interstitial lung diseases (ILDs). The study aims to evaluate how anti-fibrotic treatments affect fibrotic activity using FAPI PET/CT imaging. This phase 2 study also investigates FAP expression in various biological samples and its correlation with disease progression and treatment response. Participants will undergo FAPI PET/CT scans performed at the Nuclear Medicine department. The study includes several cohorts: before and after anti-fibrotic therapy initiation (cohort B), corticosteroid therapy for acute ILD exacerbation (cohort C), immunosuppressive treatment for non-IPF fibrosis (cohort D), and before lung procedures like transplantation or biopsy to compare imaging with tissue analysis (cohort E). The imaging involves intravenous injection of specific tracers with monitoring in a relaxed setting. During the study, participants will have PET/CT scans before and after treatment over periods ranging from weeks to years, with follow-up up to two years for some assessments. Researchers will collect biological samples such as blood, bronchoalveolar lavage (BAL), induced sputum, and exhaled breath condensate (EBC) to compare with imaging results. The main measurement is FAPI uptake on PET/CT from inclusion to three months after treatment start. Secondary outcomes include correlations between FAP expression and clinical progress, tracer comparisons, and tissue analysis from biopsies or surgeries.
CONDITIONS
Brief Title
Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults patients with a fibrotic lung disease (idiopathic pulmonary fibrosis (IPF) or non-IPF fibrotic interstitial lung disease) as defined by the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guidelines
You will not qualify if you...
- Pregnant or nursing patients
- Patients with another significant medical condition which may interfere with study completion
- Patients with an active lung neoplasm or any other active neoplasm for blood samples
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants undergo FAPI PET/CT scans and sample collection to assess fibroblast activation protein expression before and after therapy or surgery.
2 visits for PET/CT scans and sample collection
Duration - Up to 2 years
Participants are monitored for clinical evolution and correlation of FAP expression with lung function and treatment outcomes.
Periodic assessments depending on clinical follow-up and sample collection
Trial Site Locations
Total: 1 location
1
Medecine
Brussels, Belgium, 1070
Actively Recruiting
Research Team
B
Benjamin Bondue
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
0
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