RGD PET/CT Imaging in COVID-19 Patients

Completed

• Conditions: Endothelial Dysfunction; Covid19; PET Imaging

• Registration Number: NCT04596943
• Lead Sponsor: Radboud University Medical Center

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-15
• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-22
• Primary Completion: 2021-02-01
• Status Verified: 2021-03
• Study Completion: 2021-03-01
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• a microbiologically proven SARS-CoV-19 infection
• pulmonary involvement as demonstrated on recent (<1 week) chest CT, classified as CORADS 4 or 5, with indicative findings such as ill-demarcated multifocal ground glass opacities, mixed ground glass and consolidations, predominant peripheral and basal distribution, vascular thickening, round shaped and/or (reversed) halo
• More than or equal to 18 years of age;
• Ability to provide written informed consent.

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Exclusion Criteria

• Contra-indication for PET: Pregnancy; Breast-feeding; Severe claustrophobia.

• Contra-indication for administration of iodine-containing contrast agents.
• Saturation <94% at room air (without need of additional oxygen)
• Previously documented lung abnormalities that can interfere with interpretation of research scans, e.g. extensive fibrosis, known interstitial lung disease, pulmonary metastases, known pulmonary involvement of granulomatous diseases.
• Oth Estimated creatinine clearance < 30mL/min according to the Cockcroft-Gault formula (or local institutional standard method) OR oligo-uric patients (<400mL/24hr)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
uptake of [68Ga]Ga-DOTA-(RGD)2 in the lung parenchyma	2 months	The main study parameter is the uptake of \[68Ga\]Ga-DOTA-(RGD)2 in the lung parenchyma as quantified by PET/CT (SUVmean ±SD, SUVmax ±SD and SUVpeak ±SD).

Secondary Outcome Measures

Name	Time	Method
explore correlation with clinical parameters	2 months	correlation with the following clinical parameters: (time to) eventual ICU admission, length of ICU stay (days), mechanical ventilation parameters, oxygen demand, total length of hospital stay (days)
quantitative correlation with laboratory results	2 months	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)
spatial correlation with chest-CT	2 months	spatial correlation (per lung segment) with ground-glass opacities, consolidation and vascular thickening
spatial correlation with CT-subtraction	2 months	spatial correlation (per lung segment) with perfusion abnormalities as measured by CT-subtraction

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Netherlands