Overview
Sponsor-declared trial summary
Non-resolving ARDS
To relate pulmonary fibroblast activity in non-resolving ARDS patients, measured by FAPI-PET/CT, to 28 day mortality, ventilator-free days and alive at 28 days (VFD-28) and ICU length of stay.
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- 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], Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 24 Nov 2024 → ongoing
- Decision date (initial)
- 2024-10-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Cock-Hadders grant
External identifiers
- EU CT number
- 2024-517257-27-00
- EudraCT number
- 2022-003701-29
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
To relate pulmonary fibroblast activity in non-resolving ARDS patients, measured by FAPI-PET/CT, to 28 day mortality, ventilator-free days and alive at 28 days (VFD-28) and ICU length of stay.
Secondary objectives 3
- To evaluate PET/CT procedure using evaluation form and adverse event registration.
- To study the relationship between pulmonary fibroblast activity and systemic fibrotic and inflammatory blood markers.
- To relate the pulmonary fibroblast activity on [68Ga]FAPI PET/CT with respiratory cytopathology and fibrotic and inflammatory mediators collected via bronchoalveolar lavage (BAL).
Conditions and MedDRA coding
Non-resolving ARDS
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Adult (male >19 years of age and female >19 years of age) patients
- Mechanically ventilated
- Patiënt meets the criteria for non-resolving ARDS as at day 5 of the ARDS diagnosis one or more of the following criteria is true: 1. P/F ratio <200 mmHg 2. Positive End Expiratory Pressure (PEEP) at 12 cmH20 or more 3. Static lung compliance of < 50 ml/cmH20
- Deemed safe for transport by attending clinician (staff Intensivist)
- Informed consent signed by patiënt or legal representative
- For COVID-19 patients a SARS-CoV-2 PCR CT >30 is required
Exclusion criteria 3
- Whomen who are pregnant or breastfeeding
- Inability to attain informed consent
- Too unstable for transport as judged by the treating staff intensivist
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- [68Ga]FAPI uptake related to 28 days mortality
- [68Ga]FAPI uptake related to ICU stay
- [68Ga]FAPI uptake related to VFD-28
Secondary endpoints 2
- The relationship between pulmonary fibroblast activity, measured by FAPI-PET to clinically determined parameters of respiratory state (i.e. PEEP, Ppeak, lung compliance, driving pressure, mechanical power) and plasma markers of extracellular matrix and inflammation (e.g. IL-8/IL-6/TNFalpha and ProC3, C3M).2 Furthermore, we will perform a BAL to collect respiratory cytology and determine cellular phenotypes using scRNA.
- Evaluating PET/CT procedure using evaluation form and adverse event registration.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11595253 · Product
- Active substance
- (S-222-10-2-4-3-4-2-2-CYANO-44-DIFLUOROPYRROLIDIN-1-YL-2-OXOETHYLCARBAMOYL-QUINOLIN-6-YLMETHYLAMINO-PROPYLPIPERAZIN-1-YL-2-OXOETHYL-68GA-14710-TETRAAZACYCLODODECANE-147-TRIYLTRIACETATE
- Substance synonyms
- 68Ga-FAPI-46
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 220 MBq megabecquerel(s)
- Max total dose
- 220 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- UNIVERSITY MEDICAL CENTER GRONINGEN
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Research desk intensive care adults
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Research desk intensive care adults
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 | 2024-11-24 | 2024-11-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-517257-27_FAPI_ARDS-redacted | 3 |
| Recruitment arrangements (for publication) | Blanco_FAPI-ARDS_2024-517257-27-00 | 1 |
| Subject information and informed consent form (for publication) | E1_PIF_FAPI-ARDS_2024-517257-27-00_Contactpersoon_redacted | 2 |
| Subject information and informed consent form (for publication) | E1_PIF_FAPI-ARDS_2024-517257-27-00_Proefpersoon_redacted | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-24 | Netherlands | Acceptable with conditions 2024-10-18
|
2024-10-18 |