Of patients requiring mechanical ventilation in the ICU 23% meet criteria of the Acute Respiratory Distress Syndrome (ARDS). Mortality of this syndrome remains high (35-46%) in moderate and severe ARDS. In patients not recovering from ARDS, fibroblasts seem to play an important role. However, the effect of fibroblast activity on the lack of pulmonary recovery is not fully understood. The new PET tracer \[68Ga\]FAPI-46 (FAPI) allows for imaging of activated fibroblasts. The aim of this study is to explore the pulmonary fibroblast activity, measured with the FAPI PET/CT, in patients with non-resolving ARDS.
Eligibility
Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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:
* P/F ratio \<200 mmHg
* Positive End Expiratory Pressure (PEEP) of 12 cmH2O or more
* Static lung compliance of \< 50 ml/cmH2O
* Deemed safe for transport by attending clinician (staff Intensivist)
* Informed consent signed by patient or legal representative
In case of COVID-19 a SARS-CoV-2 PCR CT of \> 30 is required.
Exclusion Criteria:
* Women who are pregnant or breastfeeding
* Inability to attain informed consent
* Too unstable for transport as judged by the treating staff intensivist
Primary outcome measure(s)
Patient outcome - ICU stay — From inclusion until the end of the study (28 days after inclusion) Pulmonary FAP expression, measured by \[68Ga\]-FAPI PET/CT, correlated to 28 days of ICU stay.
Patient outcome - 28 days mortality — From inclusion until end of the study (28 days after inclusion) Pulmonary FAP expression, measured by \[68Ga\]-FAPI PET/CT, correlated to 28 days mortality.
Patient outcome - VFD-28 — From inclusion until end of the study (28 days after inclusion) Pulmonary FAP expression, measured by \[68Ga\]-FAPI PET/CT, correlated to ventilation free days of 28 days (VFD-28)
Trial sites (1)
Facility
City
Region
Status
University Medical Center Groningen
Groningen
Provincie Groningen
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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