Clinical Trial Results:
PET/CT imaging of uPAR-expression in patients with neuroendocrine tumors using 68Ga-NOTA-AE105
Summary
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EudraCT number |
2017-002312-13 |
Trial protocol |
DK |
Global end of trial date |
08 Jul 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Jul 2022
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First version publication date |
17 Jul 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 |
AK2017-1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03278275 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Rigshospitalet
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Sponsor organisation address |
Blegdamsvej 9, Copenhagen, Denmark, 2100
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Public contact |
Professor Andreas Kjær, Rigshospitalet, Department of Clinical
Physiology, Nuclear Medicine and PET, Professor Andreas Kjær, Rigshospitalet, Department of Clinical
Physiology, Nuclear Medicine and PET, akjaer@sund.ku.dk
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Scientific contact |
Professor Andreas Kjær, Rigshospitalet, Department of Clinical
Physiology, Nuclear Medicine and PET, Professor Andreas Kjær, Rigshospitalet, Department of Clinical
Physiology, Nuclear Medicine and PET, akjaer@sund.ku.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 |
08 Jul 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
08 Jul 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Jul 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 |
In this study with uPAR PET we include patients diagnosed with neuroendocrine tumors in order to investigate the tumor visualization and prognostic performance of (68Ga-NOTA-AE105) uPAR PET/CT
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Protection of trial subjects |
It is emphasized that participation in the study is voluntary and will have no influence on the otherwise planned treatment, whether the patient will participate or not. The study is conducted in accordance with the Helsinki Declaration and the Good Clinical Practice (GCP). All clinical information about the participants is protected under the act on processing of Personal Data and the Danish Health Legislation. Overall, it is considered that the project is ethically sound, as there are no significant risks associated with the uPAR PET/CT imaging procedure.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2017
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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 |
Denmark: 116
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Worldwide total number of subjects |
116
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EEA total number of subjects |
116
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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) |
47
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From 65 to 84 years |
69
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85 years and over |
0
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Recruitment
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Recruitment details |
Prospective inclusion patients with lung or gastro-entero-pancreatic neuroendocrine neoplasms. | ||||||||||||||||
Pre-assignment
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Screening details |
We prospectively included 116 patients who fullfilled inclusion and exclusion criteria. Of the 116, 17 did not undergo uPAR PET/CT (worsening of disease, n=5; withdrawal of consent, n=5; death before uPAR PET/CT, n=4; impossibility of performing uPAR PET/CT because of coronavirus disease 2019 restrictions, n=3). | ||||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
116 | ||||||||||||||||
Number of subjects completed |
116 | ||||||||||||||||
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 |
An experienced board-certified nuclear medicine physician together with an experienced board-certified radiologist analyzed side by side the PET/CT scans. The readers were masked to patient data.
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Arms
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Arm title
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Experimental arm | ||||||||||||||||
Arm description |
- | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
68Ga-NOTA-AE105
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Investigational medicinal product code |
SUB271580 - [68Ga]Ga-NOTA-AE105
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for concentrate for solution for infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
One injection of up to 236 MBq 68Ga-NOTA-AE105
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
All patients fullfilling the inclusion/exclusion criteria and included in the study | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Primary analysis set
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All patients who underwent uPAR PET/CT and had evaluable lesions (visible lesions on PET and or CT)
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Subject analysis set title |
Safety set
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All patients who underwent uPAR PET/CT
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Subject analysis set title |
Secondary analyses set - low uPAR
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Patients were dicotomized by tumor uPAR uptake in a group of low and high uptake
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Subject analysis set title |
Secondary analyses set - high uPAR
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Patients were dicotomized (by median) by their tumor uPAR uptake in low and high uptake
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End points reporting groups
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Reporting group title |
Experimental arm
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Reporting group description |
- | ||
Subject analysis set title |
Primary analysis set
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
All patients who underwent uPAR PET/CT and had evaluable lesions (visible lesions on PET and or CT)
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Subject analysis set title |
Safety set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All patients who underwent uPAR PET/CT
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Subject analysis set title |
Secondary analyses set - low uPAR
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Patients were dicotomized by tumor uPAR uptake in a group of low and high uptake
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Subject analysis set title |
Secondary analyses set - high uPAR
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Patients were dicotomized (by median) by their tumor uPAR uptake in low and high uptake
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End point title |
uPAR PET-positive tumors [1] | ||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Assessed following the performance of uPAR PET
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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: Descriptive analysis of the number of patients with uPAR positive lesions |
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No statistical analyses for this end point |
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End point title |
Progression free survival | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During at least 1 year follow-up after uPAR PET/CT
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Statistical analysis title |
Cox regression analysis | ||||||||||||||||||||
Comparison groups |
Secondary analyses set - low uPAR v Secondary analyses set - high uPAR
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Number of subjects included in analysis |
96
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||||||
Method |
Regression, Cox | ||||||||||||||||||||
Parameter type |
Hazard ratio (HR) | ||||||||||||||||||||
Point estimate |
1.87
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
1.11 | ||||||||||||||||||||
upper limit |
3.17 |
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End point title |
Overall survival | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At least one year follow-up after uPAR PET/CT
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Statistical analysis title |
Cox regression analysis | ||||||||||||||||||||
Comparison groups |
Secondary analyses set - low uPAR v Secondary analyses set - high uPAR
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Number of subjects included in analysis |
96
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Analysis specification |
Pre-specified
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Analysis type |
other [2] | ||||||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||||||
Method |
Regression, Cox | ||||||||||||||||||||
Parameter type |
Hazard ratio (HR) | ||||||||||||||||||||
Point estimate |
2.64
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
1.19 | ||||||||||||||||||||
upper limit |
5.88 | ||||||||||||||||||||
Notes [2] - Patients were dichotomized by median values |
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Adverse events information
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Timeframe for reporting adverse events |
Within 24 hours of uPAR PET/CT
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Assessment type |
Systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||
Dictionary version |
5
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Reporting groups
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Reporting group title |
All patients scanned
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Reporting group description |
All patients who underwent uPAR PET/CT | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0.1% | |||||||||||||||
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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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02 Feb 2018 |
New principal investigator |
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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. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/35058319 |