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

NCT ID: NCT06189820

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-09

Study Completion Date

2027-03-09

Brief Summary

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

Detailed Description

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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).

Conditions

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Pulmonary Fibrosis Lung Fibrosis Idiopathic Pulmonary Fibrosis FAP

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Caregivers

Interventions

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FAPI PET/CT

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medecine

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Benjamin Bondue

Role: CONTACT

+ 32 (2) 555 5758

Facility Contacts

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Benjamin Bondue

Role: primary

+ 32 (2) 555 5758

Other Identifiers

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P2022/587

Identifier Type: -

Identifier Source: org_study_id

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