RDG-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. - RDG-PET/CT imaging in COVID-19 patients.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001325-31-NL

Enrollment

Registered

2020-04-07

Start date

2020-05-20

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maximum 10 patients from the Infectious Diseases ward with proven COVID-19 infection and pulmonary abnormalities on contrast-enhanced CT undergo static PET scans after injection of 70 µg (200 MBq) [68Ga]Ga-DOTA-(RGD)2. MedDRA version: 20.1 Level: HLT Classification code 10047468 Term: Viral lower respiratory tract infections System Organ Class: 100000004855 MedDRA version: 20.1 Level: HLT Classification code 10047483 Term: Viral upper respiratory tract infections System Organ Class: 1000000048

Interventions

Product Name: [68Ga]Ga-DOTA-E-(cRGDfK)2 Pharmaceutical Form: Solution for injection INN or Proposed INN: INN not yet been requested to the WHO Other descriptive name: [68Ga]Ga-DOTA-(RGD)2 Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • A microbiologically proven SARS-CoV-19 infection; • Pulmonary involvement as demonstrated on recent (=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

Exclusion criteria: • 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).

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to demonstrate and quantitate aberrant activation of the endothelium in the lung vasculature using [68Ga]Ga-DOTA-(RGD)2 PET/CT.;Secondary Objective: 1) To assess the spatial correlation between [68Ga]Ga-DOTA-(RGD)2 uptake and abnormal findings on contrast-enhanced CT scan of the chest 2) To assess the spatial correlation between [68Ga]Ga-DOTA-(RGD)2 and subtraction CT of the chest 3) To assess the correlation between [68Ga]Ga-DOTA-(RGD)2 and blood-based biomarkers (BioMarCo-19 study, CMO 2020-6344) 4) To explore the correlation between [68Ga]Ga-DOTA-(RGD)2 uptake and clinical course of disease ;Primary end point(s): The main study parameter is the uptake of [68Ga]Ga-DOTA-(RGD)2 in the lesions as quantified by PET/CT (SUVmean ±SD, SUVmax ±SD and SUVpeak ±SD).;Timepoint(s) of evaluation of this end point: LVLS.	—

Measure

Time frame

Main Objective: The primary objective of this study is to demonstrate and quantitate aberrant activation of the endothelium in the lung vasculature using [68Ga]Ga-DOTA-(RGD)2 PET/CT.;Secondary Objective: 1) To assess the spatial correlation between [68Ga]Ga-DOTA-(RGD)2 uptake and abnormal findings on contrast-enhanced CT scan of the chest 2) To assess the spatial correlation between [68Ga]Ga-DOTA-(RGD)2 and subtraction CT of the chest 3) To assess the correlation between [68Ga]Ga-DOTA-(RGD)2 and blood-based biomarkers (BioMarCo-19 study, CMO 2020-6344) 4) To explore the correlation between [68Ga]Ga-DOTA-(RGD)2 uptake and clinical course of disease ;Primary end point(s): The main study parameter is the uptake of [68Ga]Ga-DOTA-(RGD)2 in the lesions as quantified by PET/CT (SUVmean ±SD, SUVmax ±SD and SUVpeak ±SD).;Timepoint(s) of evaluation of this end point: LVLS.

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Secondary

Measure	Time frame
Secondary end point(s): 1) spatial correlation (per lung segment) with ground-glass opacities, consolidation, vessel size and other components of CORADS system; 2) spatial correlation (per lung segment) with perfusion abnormalities as measured by subtraction CT; 3) quantitative correlation with blood counts and differentiation, ferritin, D-dimer, CRP, liver enzyme panel (ALAT, ASAT, direct and indirect bilirubin, alkaline phosphatase, gamma-GT, LDH), cytokines, as obtained by approved study BioMarCo-19 (CMO 2020-6344); 4) correlation with the following clinical parameters: ICU admission, mechanical ventilation parameters, oxygen demand, length of ICU stay (days), length of hospital stay (days). Additional study parameters are uptake in the myocardium and the lung-to-background ratio (LBR). ;Timepoint(s) of evaluation of this end point: LVLS.	—

Measure

Time frame

Secondary end point(s): 1) spatial correlation (per lung segment) with ground-glass opacities, consolidation, vessel size and other components of CORADS system; 2) spatial correlation (per lung segment) with perfusion abnormalities as measured by subtraction CT; 3) quantitative correlation with blood counts and differentiation, ferritin, D-dimer, CRP, liver enzyme panel (ALAT, ASAT, direct and indirect bilirubin, alkaline phosphatase, gamma-GT, LDH), cytokines, as obtained by approved study BioMarCo-19 (CMO 2020-6344); 4) correlation with the following clinical parameters: ICU admission, mechanical ventilation parameters, oxygen demand, length of ICU stay (days), length of hospital stay (days). Additional study parameters are uptake in the myocardium and the lung-to-background ratio (LBR). ;Timepoint(s) of evaluation of this end point: LVLS.

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Countries

Netherlands

Contacts

Public ContactNuclear Medicine Research Office

Radboud University Medical Center

Michel.deGroot@radboudumc.nl+3124367243

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026