[68Ga]Ga-DOTA-(RGD)2 PET/CT imaging of activated endothelium in lung parenchyma of COVID-19 patients.
- Conditions
- COVID-191004743810024970coronavirus infection
- Registration Number
- NL-OMON49142
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
* A microbiologically proven SARS-CoV-19 infection
* Pulmonary involvement as demonstrated on recent (<1 week) chest CT
* Enrolled in the BioMarCo-19 study (CMO2020-6344)
* More than or equal to 18 years of age;
* Ability to provide written informed consent.
* Contra-indication for PET:
o Pregnancy;
o Breast-feeding;
o Severe claustrophobia.
* Contra-indication for administration of iodine-containing contrast agents.
* Other serious illness, e.g. history of malignancies
* Estimated creatinine clearance * 30 mL/min according to the Cockcroft-Gault
formula (or local institutional standard method)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the uptake of [68Ga]Ga-DOTA-(RGD)2 in the lesions<br /><br>as quantified by PET/CT (SUVmean ±SD, SUVmax ±SD and SUVpeak ±SD). </p><br>
- Secondary Outcome Measures
Name Time Method <p>1) spatial correlation (per lung segment) with ground-glass opacities,<br /><br>consolidation, vessel size and other components of CORADS system<br /><br>2) spatial correlation (per lung segment) with perfusion abnormalities as<br /><br>measured by subtraction CT<br /><br>3) quantitative correlation with blood counts and differentiation, ferritin,<br /><br>D-dimer, CRP, liver enzyme panel (ALAT, ASAT, direct and indirect bilirubin,<br /><br>alkaline phosphatase, gamma-GT, LDH), cytokines, as obtained by approved study<br /><br>BioMarCo-19 (CMO 2020-6344)<br /><br>4) correlation with the following clinical parameters: ICU admission,<br /><br>mechanical ventilation parameters, oxygen demand, length of ICU stay (days),<br /><br>length of hospital stay (days).<br /><br>Additional study parameters are uptake in the myocardium and the<br /><br>lung-to-background ratio (LBR). </p><br>