Clinical Trial Results:
[68Ga]Ga-DOTA-(RGD)2 PET/CT imaging of activated endothelium in lung parenchyma of COVID-19 patients.
Summary
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EudraCT number |
2020-001325-31 |
Trial protocol |
NL |
Global end of trial date |
08 Jun 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Jun 2022
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First version publication date |
24 Jun 2022
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
NL73551.091.20
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04596943 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Radboud University Medical Center
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Sponsor organisation address |
Geert Grooteplein zuid 8, Nijmegen, Netherlands, 6525 GA
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Public contact |
Nuclear Medicine Research Office, Radboud University Medical Center, +31 24367243, Michel.deGroot@radboudumc.nl
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Scientific contact |
Nuclear Medicine Research Office, Radboud University Medical Center, +31 24367243, Michel.deGroot@radboudumc.nl
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Jan 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Jan 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Jun 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to demonstrate and quantitate aberrant activation of the endothelium in the lung vasculature using [68Ga]Ga-DOTA-(RGD)2 PET/CT.
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Protection of trial subjects |
Best standard of care.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 Oct 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
10
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
4
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From 65 to 84 years |
6
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment from 16-OCT-2020 up to 27-Jan-2021. 10 patients screened, 10 patients enrolled. | ||||||
Pre-assignment
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Screening details |
No pre-assignment period applicable. | ||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
Blinding not applicable.
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Arms
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Arm title
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Interventional arm | ||||||
Arm description |
Single arm, injection of radiotracer followd by PET-CT imaging. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
[89Ga]Ga-DOTA-E-[c(RGDfK)]2
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Investigational medicinal product code |
SUB130779
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Other name |
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Pharmaceutical forms |
Injection/infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
Mean dose 196 +/- 20 MBq, single injection
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Interventional arm
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Reporting group description |
Single arm, injection of radiotracer followd by PET-CT imaging. |
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End point title |
Primary End Point [1] | ||||||||
End point description |
Radiotracer uptake in lungs
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End point type |
Primary
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End point timeframe |
Overall study
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Observational trial with descriptive end points only. |
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Attachments |
SUV_lungs |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Overall study
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Adverse event reporting additional description |
CTCAE v. 4.03
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||
Dictionary version |
4.03
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events occured outside of events related to the disease. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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27 Oct 2020 |
Prior to first subject in diagnostic CE-CT was removed from inclusion criteria. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Not applicable. |