CompletedNot Applicable

RGD PET/CT Imaging in COVID-19 Patients

Netherlands10 participantsStarted 2020-10-15

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 2 months

Trial details

NCT IDNCT04596943

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-02-01

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