FAPI PET/CT to Detect Fibroblast Activity in Non-resolving ARDS (NCT06691464) | Clinical Trial Compass
By InvitationNot Applicable
FAPI PET/CT to Detect Fibroblast Activity in Non-resolving ARDS
Netherlands20 participantsStarted 2024-09-01
Plain-language summary
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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a special FAPI PET/CT scan to look at fibroblast activity in the lungs — can you explain what that scan involves and whether the radiation exposure or the contrast used is safe for someone in my condition right now?
2Since this trial is enrolling by invitation only and is focused on imaging rather than a new treatment, does participating actually change any of my care, or is it purely observational — meaning I'd receive the same ICU treatment either way?
3The trial is tracking 28-day mortality and ventilator-free days as key outcomes — does that mean the results would mainly help future ARDS patients rather than directly benefiting me during my current admission?
4Given that I'm already dealing with moderate or severe ARDS, is there any physical risk or burden involved in being moved or positioned for a PET/CT scan while I'm critically ill in the ICU?
5Are there standard treatments or management approaches for non-resolving ARDS that you'd recommend we focus on first, and would joining this imaging study in any way interfere with or delay those options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient outcome - ICU stay
Timeframe: From inclusion until the end of the study (28 days after inclusion)
2
Patient outcome - 28 days mortality
Timeframe: From inclusion until end of the study (28 days after inclusion)
3
Patient outcome - VFD-28
Timeframe: From inclusion until end of the study (28 days after inclusion)