Pulmonary FibrosisPhase 2FAPIPETNCT06189820
Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases
A Phase 2 study testing FAPI PET/CT in people with Pulmonary Fibrosis and Lung Fibrosis, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
To evaluate the effect of an anti-fibrotic treatment initiation on the fibrotic activity as assessed by FAPI PET/CT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis, Lung Fibrosis, Idiopathic Pulmonary Fibrosis
- What is being tested?
- FAPI PET/CT
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Mar 2023to 9 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Medecine
Brussels, 1070
Benjamin Bondue, + 32 (2) 555 5758, benjamin.bondue@hubruxelles.be
About this study
To evaluate the effect of an anti-fibrotic treatment initiation on the fibrotic activity as assessed by FAPI PET/CT.
Read the 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).
- Conditions
- Pulmonary Fibrosis, Lung Fibrosis, Idiopathic Pulmonary Fibrosis, FAP
- Being tested
- FAPI PET/CT
- Keywords
- Pulmonary fibrosis, FAP
- Medical subject headings
- Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI PET/CTDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
FAPI uptake on PET/CT
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
Measured: From date of inclusion till date of the second FAPI PET/CT (after 3 months)
Secondary outcomes (5)
Correlation between lung FAP expression and clinical evolution
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
Measured: From date of inclusion for a period of 2 years
Comparison of different FAPi tracers
Comparison of PET parameters on 68Ga-FAPI and 18F-FAPI images (SUVmax, SUVmean) in lungs
Measured: From date of inclusion till the second FAPi PET/CT (maximum period of 4 weeks)
Comparison of different FAPi tracers
Comparison of PET parameters of 68Ga-FAPI and 18F-FAPI images (SUVmax, SUVmean) in blood pool
Measured: 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.
Correlation between lung FAPI uptake on the PET images (SUVmean, SUVmax, TLA) and corresponding quantitative FAP assessment in blood and BAL samples.
Measured: 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)
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)
Measured: From date of inclusion until surgery, for a maximum period of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start9 Mar 2023
- Primary completion9 Mar 2027 (estimated)
- Study completion9 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189820
- Sponsor's protocol ID
- P2022/587
- Acronym
- FAPIPET
- Status last verified
- Sep 2026
- First submitted
- 22 Nov 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases
- ClinicalTrials.gov ID
- NCT06189820
- Acronym / sponsor ID
- FAPIPET / P2022/587
- Conditions
- Pulmonary Fibrosis, Lung Fibrosis, Idiopathic Pulmonary Fibrosis, FAP
- Keywords
- Pulmonary fibrosis, FAP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 9 Mar 2027 (estimated)
- Study completion
- 9 Mar 2027 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (care provider)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAPI PET/CTIn 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 | Diagnostic test | – |
Primary outcome
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
5 secondary outcomes
Correlation between lung FAP expression and clinical evolution
Time frame: 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 different FAPi tracers
Time frame: 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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FAPI PET/CT in people with Pulmonary Fibrosis and Lung Fibrosis, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Bondue (+ 32 (2) 555 5758, benjamin.bondue@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FAPI uptake on PET/CT (time frame: From date of inclusion till date of the second FAPI PET/CT (after 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.