Clinical Trial Results:
64Cu-DOTATATE PET/CT-skanning to diagnose macrophage infiltation in the heart valves of patients with infectiv endocarditis.
Summary
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EudraCT number |
2021-005501-27 |
Trial protocol |
DK |
Global end of trial date |
29 Sep 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Mar 2025
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First version publication date |
07 Mar 2025
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Other versions |
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Summary report(s) |
published article |
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 |
80843
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05432427 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Rigs
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Sponsor organisation address |
Blegdamsvej 9, copenhagen, Denmark, 2100
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Public contact |
Department of Cardiology, Rigshospitalet, 0045 35454885, katra.hadji-turdeghal@regionh.dk
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Scientific contact |
Department of Cardiology, Rigshospitalet, 0045 35456340, emil.fosboel@regionh.dk
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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 |
29 Sep 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Sep 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Sep 2023
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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 |
We hypothesize that the 64Cu-DOTATATE will show uptake in the infected vegetations on the prosthetic heart valves and increase the accuracy of the right diagnosis – thus increasing the sensitivity and specificity compared to 18F-FDG PET/CT
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Protection of trial subjects |
According to CGP guidelines
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 Apr 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Denmark: 69
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Worldwide total number of subjects |
69
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EEA total number of subjects |
69
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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) |
48
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From 65 to 84 years |
20
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85 years and over |
1
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Recruitment
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Recruitment details |
All patients were included at the Departmet of Cardiology, Rigshospitalet, Copenhagen, Denmark according to inclusion and exclusion criteria as described | ||||||
Pre-assignment
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Screening details |
In total 99 patients were screened | ||||||
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 | ||||||
Arms
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Arm title
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scans | ||||||
Arm description |
64Cu]Cu-DOTATATE and [ 18F]FDG PET/CT were performed,using established methods at the Department of ClinicalPhysiology and Nuclear Medicine at Copenhagen University Hospital, Rigshospitalet. The scans were scheduled to be per-formed in a random order after diagnosis and not more than seven days between the two scans. Because of the differenteffective half-life of the tracers, [ 18F]FDG PET/CT could be performed no earlier than 48 hours after [64Cu]Cu-DOTATATEPET/CT. If the [ 18F]FDG PET/CT scan was performed first, at least 12 hours had to pass before the subsequent [64Cu]Cu-DOTATATE PET/CT could be performed | ||||||
Arm type |
scan | ||||||
Investigational medicinal product name |
64Cu-DOTATATE
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Investigational medicinal product code |
SUB181362
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
200 MBq(+/- 10%)/ml one time administration
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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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Subject analysis sets
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Subject analysis set title |
the main study
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The sensitivity and specificity of [64Cu]Cu-DOTATATEPET/CT in the 20 cases and the 20 controls were 55%(95% CI, 33–77) and 90% (95% CI, 77–100), respec-tively. This corresponded to a PPV of 85% (95% CI,65–100) and an NPV of 67% (95% CI, 49–84) in oursample with a prevalence of 50%
The sensitivity and specificity of [ 18F]FDG PET/CT inthe 20 cases and the 20 controls were 55% (95% CI,33–77) and 75% (95% CI, 56–94), respectively. Thiscorresponded to a positive predictive value (PPV) of69% (95% CI, 46–91) and a negative predictive value(NPV) of 63% (95% CI, 43–82)
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End points reporting groups
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Reporting group title |
scans
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Reporting group description |
64Cu]Cu-DOTATATE and [ 18F]FDG PET/CT were performed,using established methods at the Department of ClinicalPhysiology and Nuclear Medicine at Copenhagen University Hospital, Rigshospitalet. The scans were scheduled to be per-formed in a random order after diagnosis and not more than seven days between the two scans. Because of the differenteffective half-life of the tracers, [ 18F]FDG PET/CT could be performed no earlier than 48 hours after [64Cu]Cu-DOTATATEPET/CT. If the [ 18F]FDG PET/CT scan was performed first, at least 12 hours had to pass before the subsequent [64Cu]Cu-DOTATATE PET/CT could be performed | ||
Subject analysis set title |
the main study
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
The sensitivity and specificity of [64Cu]Cu-DOTATATEPET/CT in the 20 cases and the 20 controls were 55%(95% CI, 33–77) and 90% (95% CI, 77–100), respec-tively. This corresponded to a PPV of 85% (95% CI,65–100) and an NPV of 67% (95% CI, 49–84) in oursample with a prevalence of 50%
The sensitivity and specificity of [ 18F]FDG PET/CT inthe 20 cases and the 20 controls were 55% (95% CI,33–77) and 75% (95% CI, 56–94), respectively. Thiscorresponded to a positive predictive value (PPV) of69% (95% CI, 46–91) and a negative predictive value(NPV) of 63% (95% CI, 43–82)
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End point title |
primary | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
April 2022 through June 2023,
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Attachments |
published article |
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Statistical analysis title |
64Cu-DOTATATE | |||||||||
Statistical analysis description |
To assess differences in SUVmax uptake between groups for [64Cu]Cu-DOTATATE and [18F] FDG PET/CT respectively, unpaired Wilcoxon rank tests were applied.
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Comparison groups |
scans v the main study
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Number of subjects included in analysis |
109
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | |||||||||
P-value |
= 0.008 [2] | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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Notes [1] - Cases vs controls 64Cu-DOTATATE [2] - For CuDOTATATE |
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Statistical analysis title |
18F-FDG | |||||||||
Comparison groups |
scans v the main study
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Number of subjects included in analysis |
109
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
= 0.003 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
April 2022 to april 2024 no serious adverse events have been reported. Only 8 participatns experienced transient symptoms after administration of the injection.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19
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Reporting groups
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Reporting group title |
All patients
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
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. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/39902600 |