ARDS (Moderate or Severe)FAPI ARDSNCT06691464
FAPI PET/CT to Detect Fibroblast Activity in Non-resolving ARDS
An observational study of ARDS (Moderate or Severe), run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- ARDS (Moderate or Severe)
- What is being tested?
- PET
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2024to Jun 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU who are mechanically ventilated and fulfil the ARDS criteria for more than 5 days.
Who may be able to join
- 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.
Who cannot join
- Women who are pregnant or breastfeeding
- Inability to attain informed consent
- Too unstable for transport as judged by the treating staff intensivist
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9715JK
About this study
Official title: [68Ga]-FAPI PET/CT to Detect Fibroblast Activity in Non-resolving ARDS, a Feasibility Study.
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.
Read the detailed description
Of patients requiring mechanical ventilation in the ICU 23% meet criteria of the Acute Respiratory Distress Syndrome (ARDS). Mortality of this syndrome is high (35-46%) in moderate and severe ARDS. The fibroproliferative phase plays an important role in patients not recovering from ARDS. Bronchoalveolar lavage (BAL) can be used to investigate this process. However, quantitative assessment using BAL of fibroblast activity in both lungs is invasive, indirect and has yielded inconsistent results. This has precluded clinical utility. New methods to assess fibroblast activity in ARDS are therefore needed. A novel tool is PET/CT with the tracer [68Ga]-FAPI-46. [68Ga]-FAPI PET has the ability for reproducible and non-invasive measurement of fibroblast activity.
Objective:
- To relate pulmonary fibroblast activity in non-resolving ARDS, measured by FAPI-PET/CT, to 28 day mortality, ventilator-free days and alive at 28 days (VFD-28) and ICU length of stay.
- To study the relationship between pulmonary fibroblast activity and systemic fibrotic and inflammatory biomarker.
- To relate the pulmonary fibroblast activity on [68Ga]FAPI PET/CT with respiratory cell phenotypes and fibrotic and inflammatory mediators collected via bronchoalveolar lavage (BAL).
Study design: This is a single center prospective observational feasibility study. We will include 20 ventilated patients with non-resolving ARDS. All mechanically ventilated patients in the ICU will be screened daily for ARDS. When ARDS is present for 5 consecutive days, patients will be included. Within 7 days after inclusion a [68Ga]FAPI-46 PET/CT scan will be performed. Within 48 hours of the PET/CT a broncho alveolar lavage and a nasal brush, will be performed. Blood will be drawn at inclusion and every 3rd day, as well as the day of the PET/CT. Daily registration of ventilatory and circulatory parameters, as well as clinical blood parameters, will be collected.
End of study: The study will end when the patient has died, is discharged from the ICU or after 28 days.
- Conditions
- ARDS (Moderate or Severe)
- Being tested
- PET
- Keywords
- ARDS, respiratory failure, FAPI, PET/CT
- Medical subject headings
- Lymphoma, Follicular, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETDiagnostic test
FAPI - PET/CT
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient outcome - ICU stay
Pulmonary FAP expression, measured by [68Ga]-FAPI PET/CT, correlated to 28 days of ICU stay.
Measured: From inclusion until the end of the study (28 days after inclusion)
Patient outcome - 28 days mortality
Pulmonary FAP expression, measured by [68Ga]-FAPI PET/CT, correlated to 28 days mortality.
Measured: From inclusion until end of the study (28 days after inclusion)
Patient outcome - VFD-28
Pulmonary FAP expression, measured by [68Ga]-FAPI PET/CT, correlated to ventilation free days of 28 days (VFD-28)
Measured: From inclusion until end of the study (28 days after inclusion)
Secondary outcomes (3)
Systemic ECM and inflammatory markers
Pulmonary FAP expression, measured by [68Ga]-FAPI PET/CT, correlated to extra cellular matrix and inflammatory parameters on the day of PET/CT.
Measured: On day of PET/CT
Respiratory ECM and inflammatory markers
Pulmonary FAP expression, measured by [68Ga]-FAPI PET/CT, correlated to BAL extra cellular matrix, inflammatory parameters and cellular phenotypes
Measured: within 48 hours before or after PET/CT
Respiratory scRNA
Around the time of the PET/CT a broncho alveolair lavage will be performed collecting respiratory system cells which will be analysed using scRNA analysis.
Measured: within 48 hours before or after PET/CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Sep 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Moderate or Severe)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691464
- Sponsor's protocol ID
- 11304
- Other IDs
- 2024-517257-27-00, 2022-003701-29, Review board UMCG, CCMO
- Acronym
- FAPI ARDS
- Status last verified
- Oct 2024
- First submitted
- 13 Nov 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided