Clinical trial · Observational
FAPI PET/CT to Detect Fibroblast Activity in Non-resolving ARDS
[68Ga]-FAPI PET/CT to Detect Fibroblast Activity in Non-resolving ARDS, a Feasibility Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ARDS (Moderate or Severe) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Patient outcome - ICU stay
- timeFrame
- From inclusion until the end of the study (28 days after inclusion)
- description
- Pulmonary FAP expression, measured by \[68Ga\]-FAPI PET/CT, correlated to 28 days of ICU stay.
- measure
- Patient outcome - 28 days mortality
- timeFrame
- From inclusion until end of the study (28 days after inclusion)
- description
- Pulmonary FAP expression, measured by \[68Ga\]-FAPI PET/CT, correlated to 28 days mortality.
- measure
- Patient outcome - VFD-28
- timeFrame
- From inclusion until end of the study (28 days after inclusion)
- description
- Pulmonary FAP expression, measured by \[68Ga\]-FAPI PET/CT, correlated to ventilation free days of 28 days (VFD-28)
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available