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

NCT ID: NCT05981885

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-09
• Study Completion Date: 2024-05-17

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.

Conditions

Post-Acute COVID-19; Post-Acute COVID-19 Infection; Post-Acute COVID-19 Syndrome; Pulmonary Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Riemer Slart, Prof MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

202100802

Identifier Type: -

Identifier Source: org_study_id