Clinical trial NCT04596943: RGD PET/CT Imaging in COVID-19 Patients
Official title: [68Ga]Ga-DOTA-(RGD)2 PET/CT Imaging of Activated Endothelium in Lung Parenchyma of COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Endothelial Dysfunction
PET Imaging
Keywords: COVID-19
endothelial dysfunction
PET imaging
RGD-peptides
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population for this pilot study exists of 10 evaluable patients with a proven SARS-CoV-19 infection and pulmonary involvement as demonstrated on chest CT, admitted to the Infectious Diseases ward. Patients presenting in the Radboud University Medical Center will be considered for recruitment, if they are over the age of 18.

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


Eligibility criteria: 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.

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)

Primary outcomes:
measure: uptake of [68Ga]Ga-DOTA-(RGD)2 in the lung parenchyma
timeFrame: 2 months
Secondary outcomes:
measure: spatial correlation with chest-CT
timeFrame: 2 months
measure: spatial correlation with CT-subtraction
timeFrame: 2 months
measure: quantitative correlation with laboratory results
timeFrame: 2 months
measure: explore correlation with clinical parameters
timeFrame: 2 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
References: