Clinical trial NCT05981885: 68Ga-FAPI PET/CT to Detect Ongoing Fibroblast Activity in Post-acute COVID-19
Official title: 68Ga-FAPI PET/CT to Detect Ongoing Fibroblast Activity in Post-acute COVID-19 With Respiratory Impairment After Hospital Discharge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Acute COVID-19
Post-Acute COVID-19 Infection
Post-Acute COVID-19 Syndrome
Pulmonary Fibrosis
Keywords: 68Ga-FAPI-04
HRCT
Post-ICU
Post high-flow Nasal Oxygen therapy
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-08-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults previously admitted to the ICU or ward requiring mechanical ventilation or high flow nasal oxygen due to their COVID-19 infection with now post-acute COVID-19 and respiratory complaints.

Brief summary: The goal of this observational study is to investigate the role fibroblasts play in the persistent respiratory complaints after a COVID-19 infection. Fibroblasts are involved in tissue remodeling and repair by creating scar-tissue (fibrosis) after tissue damage has occurred. The hypothesis is that this process of fibrosis is ongoing in patients with persistent complaints. To evaluate the roll of fibroblasts a new type of scan is used that is capable of imaging active fibroblasts, a 68Ga-FAPI PET/CT scan.

Detailed description: Rationale: The pathogenesis of post-acute COVID-19 with respiratory complaints remains unknown. We aim to explore the pulmonary pattern and fibrosis activity in patients with post-acute COVID-19 with respiratory complaints using 68Ga-FAPI Positron Emission Tomography-Computed Tomography (PET/CT) imaging.

Objective: To relate pulmonary fibroblast activity, measured by FAPI-PET/CT at least 3 months after hospital discharge, to interstitial lung abnormalities on high resolution CT (HRCT) at the same time point in post-acute COVID-19 patients with respiratory complaints.

Study design: This is a ZonMw funded single center prospective observational cohort study of post-acute COVID-19 patients with respiratory complaints.

Study population: We will recruit 20 adult patients, all post-ICU or post High-Flow Nasal Oxygen therapy due to there COVID-19 infection, with post-acute COVID-19 and respiratory complaints that will undergo 68Ga-FAPI PET/CT imaging to establish pulmonary fibrosis activity.

Main study parameters/endpoints: To assess the degree of Fibroblast Activation Protein expression on 68Ga-FAPI PET/CT at least 3 months after hospital discharge and to relate this to interstitial lung abnormalities on HRCT at the same time point.

Eligibility criteria: Inclusion Criteria:

* Male patients \>18 years and female patients \>20 years discharged from hospital after PCR-confirmed COVID-19 infection.
* Previous ICU or ward admission with high flow nasal oxygen (HFNO) or mechanical ventilation.
* Persistent respiratory complaints (shortness of breath) at least 3 months after hospital discharge.

Exclusion Criteria:

* Inability or unwilling to give informed consent.
* History of claustrophobia or feeling of inability to tolerate supine position for the PET/CT scans.
* Severe or significant comorbidity, defined as COPD GOLD stage II or higher and/or known interstitial lung disease.
* Women who are pregnant or breastfeeding.

Primary outcomes:
measure: Pulmonary SUV values
timeFrame: At time of inclusion (T0)
Secondary outcomes:
measure: Correlate biomarkers to pulmonary SUV values
timeFrame: At time of inclusion (T0)
measure: 6 minute walking test vs pulmonary SUV values
timeFrame: At time of inclusion (T0)
measure: DCLO and VC vs pulmonary SUV values
timeFrame: At time of inclusion (T0)
measure: Daily impairments (EQ-5D questionnaire) vs pulmonary SUV values
timeFrame: At time of inclusion (T0)
measure: Cellular phenotypes
timeFrame: At time of inclusion (T0)
measure: HRCT
timeFrame: At time of inclusion (T0)
measure: Follow-up HRCT
timeFrame: 10 months after T0
measure: Follow-up daily impairments (EQ-5D questionnaire) vs pulmonary SUV values
timeFrame: 10 months after T0
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Riemer Slart, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
References: