FAPI PET/CT to Detect Fibroblast Activity in Non-resolving ARDS

NCT06691464 | Enrolling By Invitation

• 5 other identifiers: 113042024-517257-27-002022-003701-29Review board UMCGCCMO
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ARDS (Moderate or Severe)

Keywords

ARDS; respiratory failure; FAPI; PET/CT

Outcome Measures

Primary Outcomes (3)

• Patient outcome - ICU stay

  Pulmonary FAP expression, measured by \[68Ga\]-FAPI PET/CT, correlated to 28 days of ICU stay.

  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.

  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)

  From inclusion until end of the study (28 days after inclusion)

Secondary Outcomes (3)

• Systemic ECM and inflammatory markers

  On day of PET/CT

• Respiratory ECM and inflammatory markers

  within 48 hours before or after PET/CT

• Respiratory scRNA

  within 48 hours before or after PET/CT

Other Outcomes (1)

• Nasal brush scRNA

  48 hours before or after the PET/CT

Interventions

PET DIAGNOSTIC_TEST

FAPI - PET/CT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU who are mechanically ventilated and fulfil the ARDS criteria for more than 5 days.

You may qualify if:

• 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.

You may not qualify if:

• Women who are pregnant or breastfeeding
• Inability to attain informed consent
• Too unstable for transport as judged by the treating staff intensivist

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9715JK, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Broncho alveolair lavage (BAL) for respiratory cytology allowing for scRNA analysis. Blood serum and plasma. Nose swabs

MeSH Terms

Conditions

Lymphoma, Follicular; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2024-10

Locations

NL (1)