Clinical Trial Results:
MAGnetic versus STAndard technique for sentinel node biopsy in breast cancer compared in a Randomised controlled trial
Summary
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EudraCT number |
2015-000549-21 |
Trial protocol |
GB |
Global end of trial date |
20 Feb 2017
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Results information
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Results version number |
v1 |
This version publication date |
04 Oct 2019
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First version publication date |
04 Oct 2019
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Other versions |
v2 |
Summary report(s) |
Cancelled Before Active Statement |
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 |
MAGSTAR
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Additional study identifiers
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ISRCTN number |
ISRCTN20200149 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
U1111-1164-0844 | ||
Other trial identifiers |
Trialregister.nl (Dutch registration): Pending | ||
Sponsors
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Sponsor organisation name |
King's College London
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Sponsor organisation address |
The Strand, London, United Kingdom, WC2R 2LS
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Public contact |
Mr Michael Douek, King's College London, 44 2071886380, michael.douek@kcl.ac.uk
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Scientific contact |
Mr Michael Douek, King's College London, 44 2071886380, michael.douek@kcl.ac.uk
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Sponsor organisation name |
Guy's & St Thomas' NHS Foundation Trust
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Sponsor organisation address |
F16 Tower Wing, Guy's Hospital, Great Maze Pond, London, United Kingdom, SE19RT
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Public contact |
Mr Michael Douek, Guy's and St Thomas' NHS Foundation Trust, 44 2071886380, michael.douek@kcl.ac.uk
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Scientific contact |
Mr Michael Douek, Guy's and St Thomas' NHS Foundation Trust, 2071885732 2071886380, michael.douek@kcl.ac.uk
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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 |
20 Feb 2017
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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 |
20 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 |
To determine whether the magnetic technique (involving the magnetic tracer and magnetometer) can be used instead of the standard 'dual' technique (blue dye and radioactive injection) to locate lymph nodes during breast cancer surgery.
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Protection of trial subjects |
N/A
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Feb 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 |
United Kingdom: 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, this trial was discontinued with no participants enrolled in the trial | ||||||
Pre-assignment
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Screening details |
N/A | ||||||
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 |
N/A
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Arms
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Arm title
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Nanocoll | ||||||
Arm description |
Nanocoll 0.3 ml | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Nanocoll
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Dosage would have been one injection 0.3 ml subcutaneously
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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 |
Nanocoll
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Reporting group description |
Nanocoll 0.3 ml |
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End point title |
Overall SLNB identification rate [1] | ||||||||
End point description |
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
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End point type |
Primary
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End point timeframe |
N/A
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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 subjects were enrolled in the trial hence results are not available |
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Notes [2] - No subjects were enrolled in the trial hence results are not available |
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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 |
All adverse events occurring during the course of the clinical trial were to be collected.
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Adverse event reporting additional description |
N/A
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Nanocoll
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Reporting group description |
Nanocoll 0.3 ml | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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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 subjects were enrolled in the trial hence results are not available |
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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. | |||
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial. |