NCT04596943

RGD PET/CT Imaging in COVID-19 Patients

[68Ga]Ga-DOTA-(RGD)2 PET/CT Imaging of Activated Endothelium in Lung Parenchyma of COVID-19 Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim: We aim to evaluate αvβ3 integrin expression in proven COVID-19 infected patients with indicative findings on routine contrast-enhanced CT using \[68Ga\]Ga-DOTA-(RGD)2. If activated vascular endothelium in the lung parenchyma proceeds ARDS, as frequently observed during COVID-19 infection, imaging αvβ3 integrin expression using PET/CT could have potential as a clinical tool to characterize patients at early stages during disease and guide development of novel treatments targeting the vascular endothelium. Study design: This is a prospective, observational non-randomized pilot study. Maximum 10 patients will undergo a \[68Ga\]Ga-DOTA-(RGD)2 PET/CT scan and CT-subtraction scan in the same procedure. 10-minutes/bed position static \[68Ga\]Ga-DOTA-(RGD)2 PET/CT scans of the thorax will be acquired starting at 60 minutes post injection. Study population: Maximum 10 patients from the Infectious Diseases ward with proven COVID-19 infection and indicative pulmonary abnormalities on contrast-enhanced CT (CORADS 4-5) undergo PET/CT scans after injection of 70 μg (200 MBq) \[68Ga\]Ga-DOTA-(RGD)2 and CT-subtraction. Intervention: All patients will undergo a \[68Ga\]Ga-DOTA-(RGD)2 PET/CT scan, and in the same procedure, a CT-subtraction scan. Primary study objective: The primary objective of this study is to demonstrate and quantitate activation of the endothelium in the lung vasculature using \[68Ga\]Ga-DOTA-(RGD)2 PET/CT. Secondary study objectives: 1. To assess the spatial correlation between \[68Ga\]Ga-DOTA-(RGD)2 uptake and abnormal findings on routine contrast-enhanced CT scan of the chest 2. To assess the spatial correlation between \[68Ga\]Ga-DOTA-(RGD)2 and CTS of the lung parenchyma 3. To assess the correlation between \[68Ga\]Ga-DOTA-(RGD)2 and laboratory results 4. To explore the correlation between \[68Ga\]Ga-DOTA-(RGD)2 uptake and clinical course of disease

Conditions

• Covid19
• Endothelial Dysfunction
• PET Imaging

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	[68Ga]Ga-DOTA-(RGD)2 PET/CT	We have developed a dimeric cyclic RGD peptide conjugated with DOTA as a chelator. If labeled with the positron emitting radionuclide Gallium-68 (68Ga), \[68Ga\]Ga-DOTA-(RGD)2 can be used to visualize αvβ3 integrin expression with PET

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-02-01
• Completion: 2021-03-01
• First posted: 2020-10-22
• Last updated: 2021-04-27

Locations

1 site across 1 country: Netherlands