RGD PET/CT Imaging in COVID-19 Patients

NCT ID: NCT04596943

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2021-03-01

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

Conditions

Covid19; Endothelial Dysfunction; PET Imaging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

RGD-PET/CT

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboudumc

Nijmegen, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 37460572 (View on PubMed)

Other Identifiers

2020-001325-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NL73551.091.20

Identifier Type: -

Identifier Source: org_study_id