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
- Are there results?
- None posted in the registry
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.
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.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [68Ga]-FAPI PET/CT to Detect Fibroblast Activity in Non-resolving ARDS, a Feasibility Study.
- ClinicalTrials.gov ID
- NCT06691464
- Acronym / sponsor ID
- FAPI ARDS / 11304
- Conditions
- ARDS (Moderate or Severe)
- Keywords
- ARDS, respiratory failure, FAPI, PET/CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU who are mechanically ventilated and fulfil the ARDS criteria for more than 5 days.
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (3 listed)
- Women who are pregnant or breastfeeding
- Inability to attain informed consent
- Too unstable for transport as judged by the treating staff intensivist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PETFAPI - PET/CT | Diagnostic test | – |
Primary outcome
Patient outcome - ICU stay
Time frame: 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
Time frame: 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
Time frame: 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)
3 secondary outcomes
Systemic ECM and inflammatory markers
Time frame: On day of PET/CT
Respiratory ECM and inflammatory markers
Time frame: within 48 hours before or after PET/CT
Respiratory scRNA
Time frame: within 48 hours before or after PET/CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS (Moderate or Severe), run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient outcome - ICU stay (time frame: From inclusion until the end of the study (28 days after inclusion)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.