Overview
Sponsor-declared trial summary
Progressive Pulmonary Fibrosis (PPF)
To test the feasibility of differentiating predominant active fibrosis and predominant inflammation using PET imaging with FAPI in patients with PPF.
Key facts
- Sponsor
- St Antonius Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 24 Jan 2025 → ongoing
- Decision date (initial)
- 2024-09-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Antonius Research Fund (Antonius Onderzoeksfonds)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
To test the feasibility of differentiating predominant active fibrosis and predominant inflammation using PET imaging with FAPI in patients with PPF.
Secondary objectives 2
- Determining activity thresholds for positive FAPI-PET/CT confirming active fibrosis.
- Investigate the correlation between baseline FAPI activity and ILD extent/degree of reticulation on HRCT as well as serum biomarkers for inflammation.
Conditions and MedDRA coding
Progressive Pulmonary Fibrosis (PPF)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10037383 | Pulmonary fibrosis | 100000004855 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-503686-26-00 | PET/CT imaging with FAPI as a biomarker for the distinction between predominant active fibrotic and inflammatory phenotypes in patients with progressive pulmonary fibrosis: The FIBRO-PET study. | St Antonius Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- ≥ 18 years of age
- New diagnosis of PPF
- A minimum of 20% of lung parenchyma is aberrant (fibrosis, inflammation or both)
- MDT indication for treatment with either immunosuppressive drugs or antifibrotic drug
Exclusion criteria 5
- Prior or current treatment with antifibrotic drugs
- Active malignancy
- Inability to undergo a PET/CT at the Sint Antonius Hospital
- Incapacity to give informed consent personally
- Pregnancy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- FAPI activity concentration in patients with predominant active fibrosis and predominant inflammation
Secondary endpoints 2
- Activity thresholds for positive FAPI-PET/CT confirming active fibrosis,
- Correlation between baseline FAPI activity and ILD extent/degree of reticulation on HRCT as well as serum biomarkers for inflammation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10908933 · Product
- Active substance
- [AL18FFFAPI-74
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Not Authorised
- MA holder
- ERASMUS MC
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
St Antonius Hospital
- Sponsor organisation
- St Antonius Hospital
- Address
- Koekoekslaan 1
- City
- Nieuwegein
- Postcode
- 3435 CM
- Country
- Netherlands
Scientific contact point
- Organisation
- St Antonius Hospital
- Contact name
- Andor van den Hoven
Public contact point
- Organisation
- St Antonius Hospital
- Contact name
- Andor van den Hoven
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2025-01-24 | 2025-01-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-503686-26-00 | 1.3 |
| Protocol (for publication) | D1_Protocol 2023-503686-26-00_clean | 1.3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1.2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_Clean | 1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF FIBRO-PET study | 1.3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF FIBRO-PET study_clean | 1.3 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ENG 2023-503686-26-00 | 1.2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NL EU 2023-503686-26-00 | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-24 | Netherlands | Acceptable 2024-09-20
|
2024-09-20 |