RGD PET/CT Imaging in COVID-19 Patients

NCT04596943 | Completed DMC

• 2 other identifiers: NL73551.091.202020-001325-31
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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. 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. 2.To assess the spatial correlation between \[68Ga\]Ga-DOTA-(RGD)2 and CTS of the lung parenchyma
3. 3.To assess the correlation between \[68Ga\]Ga-DOTA-(RGD)2 and laboratory results
4. 4.To explore the correlation between \[68Ga\]Ga-DOTA-(RGD)2 uptake and clinical course of disease

Conditions

Covid19; Endothelial Dysfunction; PET Imaging

Keywords

COVID-19; endothelial dysfunction; PET imaging; RGD-peptides

Outcome Measures

Primary Outcomes (1)

• uptake of [68Ga]Ga-DOTA-(RGD)2 in the lung parenchyma

  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).

  2 months

Secondary Outcomes (4)

• spatial correlation with chest-CT

  2 months

• spatial correlation with CT-subtraction

  2 months

• quantitative correlation with laboratory results

  2 months

• explore correlation with clinical parameters

  2 months

Interventions

[68Ga]Ga-DOTA-(RGD)2 PET/CT DIAGNOSTIC_TEST

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

Also known as: RGD-PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, 6500HB, Netherlands

Location

Related Publications (1)

• van Genugten EAJ, van Lith TJ, van den Heuvel FMA, van Steenis JL, Ten Heggeler RM, Brink M, Rodwell L, Meijer FJA, Lobeek D, Hagmolen Of Ten Have W, van de Veerdonk FL, Netea MG, Prokop M, Nijveldt R, Tuladhar AM, Aarntzen EHJG. Gallium-68 labelled RGD PET/CT imaging of endothelial activation in COVID-19 patients. Sci Rep. 2023 Jul 17;13(1):11507. doi: 10.1038/s41598-023-37390-9.

  PMID: 37460572 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 22, 2020
• Study Start: October 15, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)