Clinical Trial Results:
Dynamics and tracer distribution of Tilmanocept using combined subareolar and peritumoral injection technique for scintigraphic sentinel lymph node detection in early stage breast cancer.
Summary
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EudraCT number |
2019-002597-32 |
Trial protocol |
BE |
Global end of trial date |
05 Jan 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Mar 2022
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First version publication date |
20 Mar 2022
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Other versions |
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Summary report(s) |
BC5331_EudraCT_Statement of discontinuation |
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 |
AGO/2019/003
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Ghent University Hospital
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Sponsor organisation address |
Corneel Heymanslaan 10, Ghent, Belgium, 9000
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Public contact |
HIRUZ CTU, University Hospital Ghent, +32 9 3320500, leen.geets@uzgent.be
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Scientific contact |
HIRUZ CTU, University Hospital Ghent, +32 9 3320500, leen.geets@uzgent.be
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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 |
05 Jan 2021
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Jan 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 |
Documenting the distribution of 99m-Tc Tilmanocept at multiple timepoints post-injection (combined peritumoral and subareolar) and comparing this data with the distribution of 99m-Tc nanocoll at the same timepoints.
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Protection of trial subjects |
Ethics review and approval, informed consent, supportive care and routine monitoring.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Oct 2019
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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 |
Belgium: 99999
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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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) |
99999
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
99999 is "Not applicable" value or 0 participants. | |||||||||
Pre-assignment
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Screening details |
Inclusion: - Women with newly diagnosed stage 1 or 2 breast cancer - Clinically “node negative” (no clinically enlarged lymph nodes) - Equal or more than 18 years old | |||||||||
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 |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Assessor | |||||||||
Arms
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Are arms mutually exclusive |
No
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Arm title
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99m-Technetium-Tilmanocept | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
99m-Technetium-Tilmanocept
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Radiopharmaceutical precursor, solution
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Routes of administration |
Injection
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Dosage and administration details |
74MBq divided over 2 doses of 0,5mL each
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Arm title
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99m-Technetium-albumine nanocolloid | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
99m-technetium-albumine-nanocolloid
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Radiopharmaceutical precursor, solution
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Routes of administration |
Injection
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Dosage and administration details |
74MBq divided over 2 doses of 0,5mL each
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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 |
99m-Technetium-Tilmanocept
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Reporting group description |
- | ||
Reporting group title |
99m-Technetium-albumine nanocolloid
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Reporting group description |
- |
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End point title |
Distribution pattern analysed [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
after 24 hours
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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: No statistical analysis done as no patients have been recruited for this study |
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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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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
24
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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 adverse events have been reported as no patients have been recruited |
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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 |