*[68Ga]FAPI PET/CT to detect fibroblast activity in non-resolving ARDS patients at the ICU*

• Conditions: COVID 19; ARDS; shocklong; 10047438; 10024970

• Registration Number: NL-OMON56625
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:

• Adult (male >= 20 years of age and female >= 20 years of age) patients
• Mechanically ventilated
• Patient meets the criteria for non-resolving ARDS as at day 5 of the ARDS
diagnosis one or more of the following criteria is true:
o P/F ratio <300 mmHg
o Positive End Expiratory Pressure (PEEP) at 12 cmH2O or more
o Static lung compliance of < 50 ml/cmH2O
• Deemed safe for transport by treating clinician (staff Intensivist)
• Informed consent signed by patient or relative

In case of COVID-19 non-resolving ARDS the following criteria must be met:

• Adult (male >= 20 years of age and female >= 20 years of age) patients
• Mechanically ventilated
• Patient meets the criteria for non-resolving ARDS as SARS-CoV-2 PCR CT >30
and one or more of the following criteria is true:
o P/F ratio <300 mmHg
o Positive End Expiratory Pressure (PEEP) at 12 cmH2O or more
o Static lung compliance of < 50 ml/cmH2O
• Deemed safe for transport by treating clinician (staff Intensivist)
• Informed consent signed by patient or relative

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:

• Women who are pregnant or breastfeeding
• Inability to attain informed consent
• Too unstable for transport as judged by the treating staff intensivist

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To quantify pulmonal fibroblast activity via [68Ga]-FAPI PET in non-resolving<br /><br>ARDS patients in the ICU and the relation with disease specific survival,<br /><br>length of stay at the ICU and ventilator free days at day 28.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To study the relationship between pulmonal [68Ga]-FAPI uptake and systemic<br /><br>blood markers of inflammation and extracellular matrix remodelling.</p><br>