(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Acute respiratory distress syndrome (non-resolving)

Inclusion criteria

• {"criterion_text":"- Adult (male >19 years of age and female >19 years of age) patients"}
• {"criterion_text":"- Mechanically ventilated"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Deemed safe for transport by attending clinician (staff Intensivist)"}
• {"criterion_text":"- Informed consent signed by patiënt or legal representative"}
• {"criterion_text":"- For COVID-19 patients a SARS-CoV-2 PCR CT >30 is required"}

Exclusion criteria

• {"criterion_text":"- Whomen who are pregnant or breastfeeding"}
• {"criterion_text":"- Inability to attain informed consent"}
• {"criterion_text":"- Too unstable for transport as judged by the treating staff intensivist"}

Primary endpoints

• {"endpoint_text":"- [68Ga]FAPI uptake related to 28 days mortality","definition_or_measurement_approach":"Pulmonary fibroblast activity measured by [68Ga]FAPI PET/CT uptake and related to 28-day mortality."}
• {"endpoint_text":"- [68Ga]FAPI uptake related to ICU stay","definition_or_measurement_approach":"Pulmonary fibroblast activity measured by [68Ga]FAPI PET/CT uptake and related to ICU length of stay."}
• {"endpoint_text":"- [68Ga]FAPI uptake related to VFD-28","definition_or_measurement_approach":"Pulmonary fibroblast activity measured by [68Ga]FAPI PET/CT uptake and related to ventilator-free days over 28 days (VFD-28)."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"FAPI-PET uptake correlated with clinical respiratory parameters (PEEP, Ppeak, lung compliance, driving pressure, mechanical power), plasma ECM and inflammatory markers (e.g. IL-8, IL-6, TNFalpha, ProC3, C3M), and bronchoalveolar lavage (BAL) cytology with single-cell RNA (scRNA) phenotyping."}
• {"endpoint_text":"- Evaluating PET/CT procedure using evaluation form and adverse event registration.","definition_or_measurement_approach":"Assessment using a PET/CT evaluation form and recording of adverse events."}

Netherlands

Earliest CTIS Part Ii Submission Date

17-10-2024

Latest Decision Or Authorization Date

18-10-2024

Processing Time Days

1

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands