Clinical Trial Results:
Phase II trial: uPAR-PET for preoperative staging of breast cancer patients
Summary
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EudraCT number |
2015-004503-23 |
Trial protocol |
DK |
Global end of trial date |
10 Feb 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Jan 2021
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First version publication date |
01 Jan 2021
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Other versions |
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Summary report(s) |
Status April 4 2018 Status December 2020 - Results |
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 |
CS-2015-1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02681640 | ||
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, akjaer@sund.ku.dk
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Scientific contact |
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 |
04 Apr 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 Feb 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Feb 2017
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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 sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT for detection of lymph node metastases will be tested by observer-blinded readings (two separate teams) and compared to diagnostic performance of conventional preoperative diagnostic workup procedures. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection (SN/ALND). Primary end point dichotomized: +/- lymph node metastases in ipsilateral axilla
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Protection of trial subjects |
This study was conducted in accordance with International Code of Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country in which the study was conducted.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2016
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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: 50
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Worldwide total number of subjects |
50
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EEA total number of subjects |
50
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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) |
31
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From 65 to 84 years |
19
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85 years and over |
0
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Recruitment
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Recruitment details |
50 patients were recruited at Rigshospitalet, Copenhagen University Hospital in the period Feburary 1 2016 to February 10 2017 | ||||||||||
Pre-assignment
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Screening details |
54 patients were screened and were found eligible for inclusion in the study. However, 4 patients did not receive the radioligand due to technical failure of radioligand production and were excluded from the study | ||||||||||
Period 1
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Period 1 title |
Intervention (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 |
observer-blinded readings of 68Ga-NOTA-AE105 PET/CT (two separate teams consisting of 1 experienced, board-certified specialist in Nuclear Medicine and 1 experienced, board-certified specialist in radiology
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Arms
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Arm title
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Experimental arm | ||||||||||
Arm description |
All included patients | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
68Ga-NOTA-AE105
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Investigational medicinal product code |
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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 bolus use
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Dosage and administration details |
One injection of up to 200 Mbq
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Baseline characteristics reporting groups
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Reporting group title |
Intervention (overall period)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Experimental arm
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Reporting group description |
All included patients |
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End point title |
Sensitivity and specificity of uPAR-PET (reader team 1) [1] | ||||||||||||||
End point description |
Sensitivity and specificity for detection of lymph node metastases on a per patient basis.
Sensitivity (reader team 1): 37.0% [19.4-57.6%]
Specificity (reader team 1): 86.4% [65.1-97.1%]
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End point type |
Primary
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End point timeframe |
Whole study period
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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 statistics included (95% CI) on sensitivity and specificity. No statistical differences in sensitivity (team 1: uPAR-PET/CT vs. US+FNB: p=0.56; team 2: uPAR-PET/CT vs. US+FNB p=0.18) or specificity (team 1: uPAR-PET/CT vs. US+FNB p=0.08; Team 2: uPAR-PET/CT vs. US+FNB p=0.16) were found. |
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No statistical analyses for this end point |
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End point title |
Sensitivity and specificity of uPAR-PET (reader team 2) [2] | ||||||||||||||
End point description |
Sensitivity and specificity for detection of lymph node metastases on a per patient basis.
Sensitivity (reader team 2): 29.6% [13.8-50.2%]
Specificity (reader team 2): 90.9% [70.8-98.9%]
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End point type |
Primary
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End point timeframe |
Whole study period
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Notes [2] - 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 statistics included (95% CI) on sensitivity and specificity. No statistical differences in sensitivity (team 1: uPAR-PET/CT vs. US+FNB: p=0.56; team 2: uPAR-PET/CT vs. US+FNB p=0.18) or specificity (team 1: uPAR-PET/CT vs. US+FNB p=0.08; Team 2: uPAR-PET/CT vs. US+FNB p=0.16) were found. |
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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 |
??? 2016 -10 Feb 2017
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Adverse event reporting additional description |
Events was considered as related to the IMP if they occurred during the period from the time of injection of the tracer and up to 24 hours after the injection. Events / Adverse reactions occurring later than 24 hours after injection was not registered.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
All participants
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Reporting group description |
- | ||||||||||||||||||||||||
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 were reported. This was as expected, as 68Ga-NOTA-AE105 has no known adverse effects |
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||
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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 |