Covid19NCT04596943
RGD PET/CT Imaging in COVID-19 Patients
An observational study of Covid19 and Endothelial Dysfunction, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Endothelial Dysfunction, PET Imaging
- What is being tested?
- [68Ga]Ga-DOTA-(RGD)2 PET/CT
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Oct 2020to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: [68Ga]Ga-DOTA-(RGD)2 PET/CT Imaging of Activated Endothelium in Lung Parenchyma of COVID-19 Patients
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.
Read more
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:
- To assess the spatial correlation between [68Ga]Ga-DOTA-(RGD)2 uptake and abnormal findings on routine contrast-enhanced CT scan of the chest
- To assess the spatial correlation between [68Ga]Ga-DOTA-(RGD)2 and CTS of the lung parenchyma
- To assess the correlation between [68Ga]Ga-DOTA-(RGD)2 and laboratory results
- To explore the correlation between [68Ga]Ga-DOTA-(RGD)2 uptake and clinical course of disease
- Conditions
- Covid19, Endothelial Dysfunction, PET Imaging
- Being tested
- [68Ga]Ga-DOTA-(RGD)2 PET/CT
- Keywords
- COVID-19, endothelial dysfunction, PET imaging, RGD-peptides
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-DOTA-(RGD)2 PET/CTDiagnostic test
Also called RGD-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
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 months
Secondary outcomes (4)
spatial correlation with chest-CT
spatial correlation (per lung segment) with ground-glass opacities, consolidation and vascular thickening
Measured: 2 months
spatial correlation with CT-subtraction
spatial correlation (per lung segment) with perfusion abnormalities as measured by CT-subtraction
Measured: 2 months
quantitative correlation with laboratory results
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)
Measured: 2 months
explore correlation with clinical parameters
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)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start15 Oct 2020
- Primary completion1 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596943
- Sponsor's protocol ID
- NL73551.091.20
- Other IDs
- 2020-001325-31
- Status last verified
- Mar 2021
- First submitted
- 20 Oct 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37460572
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [68Ga]Ga-DOTA-(RGD)2 PET/CT Imaging of Activated Endothelium in Lung Parenchyma of COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04596943
- Acronym / sponsor ID
- NL73551.091.20
- Conditions
- Covid19, Endothelial Dysfunction, PET Imaging
- Keywords
- COVID-19, endothelial dysfunction, PET imaging, RGD-peptides
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the spatial correlation between [68Ga]Ga-DOTA-(RGD)2 uptake and abnormal findings on routine contrast-enhanced CT scan of the chest
- To assess the spatial correlation between [68Ga]Ga-DOTA-(RGD)2 and CTS of the lung parenchyma
- To assess the correlation between [68Ga]Ga-DOTA-(RGD)2 and laboratory results
- To explore the correlation between [68Ga]Ga-DOTA-(RGD)2 uptake and clinical course of disease
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-DOTA-(RGD)2 PET/CTAlso: RGD-PET/CTWe 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 | Diagnostic test | – |
Primary outcome
uptake of [68Ga]Ga-DOTA-(RGD)2 in the lung parenchyma
Time frame: 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).
4 secondary outcomes
spatial correlation with chest-CT
Time frame: 2 months
spatial correlation with CT-subtraction
Time frame: 2 months
quantitative correlation with laboratory results
Time frame: 2 months
explore correlation with clinical parameters
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Derived from this study: PubMed 37460572van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Endothelial Dysfunction, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uptake of [68Ga]Ga-DOTA-(RGD)2 in the lung parenchyma (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04596943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.