Official Title
68Ga-FAPI PET/CT to Detect Ongoing Fibroblast Activity in Post-acute COVID-19 With Respiratory Impairment After Hospital Discharge
Brief Summary

The goal of this observational study is to investigate the role fibroblasts play in thepersistent respiratory complaints after a COVID-19 infection. Fibroblasts are involved intissue remodeling and repair by creating scar-tissue (fibrosis) after tissue damage hasoccurred. The hypothesis is that this process of fibrosis is ongoing in patients withpersistent complaints. To evaluate the roll of fibroblasts a new type of scan is usedthat 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.

Completed
Post-Acute COVID-19
Post-Acute COVID-19 Infection
Post-acute COVID-19 Syndrome
Pulmonary Fibrosis
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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Netherlands
Locations

University Medical Center Groningen
Groningen 2755251, Netherlands

Riemer Slart, Prof MD PhD, Principal Investigator
University Medical Center Groningen

ZonMw: The Netherlands Organisation for Health Research and Development
NCT Number
Keywords
68Ga-FAPI-04
HRCT
Post-ICU
Post high-flow Nasal Oxygen therapy
MeSH Terms
Post-Acute COVID-19 Syndrome
Pulmonary Fibrosis