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]
- Decision date (initial)
- 2024-03-01
- 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 |
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 | Not authorised | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-10 | Netherlands | Not acceptable 2024-03-01
|
2024-03-01 |