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

NCT05981885 | Completed

• 1 other identifier: 202100802
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Pulmonary SUV values

  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).

  At time of inclusion (T0)

Secondary Outcomes (8)

• Correlate biomarkers to pulmonary SUV values

  At time of inclusion (T0)

• 6 minute walking test vs pulmonary SUV values

  At time of inclusion (T0)

• DCLO and VC vs pulmonary SUV values

  At time of inclusion (T0)

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

  At time of inclusion (T0)

• Cellular phenotypes

  At time of inclusion (T0)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and nose epithelium for single cell RNA analysis

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Riemer Slart, Prof MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: August 8, 2023
• Study Start: June 9, 2022
• Primary Completion: November 21, 2023
• Study Completion: May 17, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Directly after publication
• Access Criteria: Only investigators whose proposed use of data is for individual participant data meta-analysis and in line with the signed informed consent are eligible for sharing

Locations

NL (1)