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Completed

NCT Number: NCT05981885

68Ga-FAPI PET/CT to Detect Ongoing Fibroblast Activity in Post-acute COVID-19

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.

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Key information

Conditions

Post-Acute COVID-19 COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Fibrosis Infections Lung Diseases Lung Diseases, Interstitial Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Infection Post-Acute COVID-19 Syndrome Post-Infectious Disorders Pulmonary Fibrosis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Pulmonary SUV values

    Time frame: At time of inclusion (T0)

    Based on the FAPI PET/CT scan 3-dimensinal volumes of intrest (VOI) are drawn of high FAPI uptake areas (leasions) and non-uptake areas. Using these VOIs SUV values and metabolic active volume (MAV) can be calculated which then can be used to calculate: total lesion FAPI (TL-FAPI), whole-lung FAPI-MAV (wl FAPI-MAV), wlSUVmean and whole lung TL-FAPI (wlTL-FAPI).

Secondary outcomes

  1. Correlate biomarkers to pulmonary SUV values

    Time frame: At time of inclusion (T0)

    A correlation between the pulmonary FAPI uptake, reported as SUV values (see outcome 1) will be correlated with fibrosis and inflammatory specific biomarkers using Pearson's or Spearman's test.

  2. 6 minute walking test vs pulmonary SUV values

    Time frame: At time of inclusion (T0)

    The total walked distance in meters during 6 minutes is correlated with pulmonary FAPI uptake, reported as SUV values (see outcome 1) using Pearson's or Spearman's test.

  3. DCLO and VC vs pulmonary SUV values

    Time frame: At time of inclusion (T0)

    Pulmonary FAPI uptake, reported as SUV values (see outcome 1), will be correlated with DCLO and VC using Pearon's or Spearman's test.

  4. Daily impairments (EQ-5D questionnaire) vs pulmonary SUV values

    Time frame: At time of inclusion (T0)

    Pulmonary FAPI uptake, reported as SUV values (see outcome 1), will be correlated with self-reported daily impairments per category as measured by the EQ-5D questionnaire using Pearson's or Spearman's test.

  5. Cellular phenotypes

    Time frame: At time of inclusion (T0)

    Pulmonary FAPI uptake, reported as SUV values (see outcome 1), will be correlated to systemic and upper respiratory tract cellular phenotypes determined by single cell RNA sequencing using Pearon's or Spearmen's test.

  6. HRCT

    Time frame: At time of inclusion (T0)

    Pulmonary FAPI uptake, reported as SUV values (see outcome 1), will be correlated to HRCT findings: extent of disease (0-100%), reticular pattern (0-100%), portion of groundglass (0-100%), coarness (0-3), honey combing (Yes/No), Distribution groundglass, crazy-paving pattern (Yes/No), fibrosis (Yes/No), Bronchiectasis (Yes/No), Emfyseem (Yes/No) and Pleural effusion (Yes/No).

  7. Follow-up HRCT

    Time frame: 10 months after T0

    Pulmonary FAPI uptake, reported as SUV values (see outcome 1), will be correlated to HRCT findings in case of persistent respiratory complaints 8-10 months after T0. Findings that are correlated are: extent of disease (0-100%), reticular pattern (0-100%), portion of groundglass (0-100%), coarness (0-3), honey combing (Yes/No), Distribution groundglass, crazy-paving pattern (Yes/No), fibrosis (Yes/No), Bronchiectasis (Yes/No), Emfyseem (Yes/No) and Pleural effusion (Yes/No).

  8. Follow-up daily impairments (EQ-5D questionnaire) vs pulmonary SUV values

    Time frame: 10 months after T0

    Pulmonary FAPI uptake, reported as SUV values (see outcome 1), will be correlated with self-reported daily impairments per category as measured by the EQ-5D questionnaire using Pearson's or Spearman's test.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: FAPI CLIMATE

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 8, 2023
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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