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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029475
Receipt No. R000033678
Scientific Title Acceleration by a small neodymium magnet in sentinel biopsy technique using magnetic nanoparticles and a handheld magnetometer
Date of disclosure of the study information 2017/10/15
Last modified on 2018/12/31

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Basic information
Public title Acceleration by a small neodymium magnet in sentinel biopsy technique using magnetic nanoparticles and a handheld magnetometer
Acronym SLNB accelerated by a neodymium magnet
Scientific Title Acceleration by a small neodymium magnet in sentinel biopsy technique using magnetic nanoparticles and a handheld magnetometer
Scientific Title:Acronym SLNB accelerated by a neodymium magnet
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Comparing standard technique SLNB in breast cancer with SLNB performed using magnetic nanoparticles and a handheld magnetometer and accelerated by a small neodymium magnet
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes SLN detection rate using the new system
Key secondary outcomes 1.SLN detection rate using standard technique
2.Comparing detection of Blue node, Hot node and SPIO node
3.The rate to coincide nodes detected using standard technique with using the new technique
4.The factors which influences detection rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Additon repeated motion of a magnet to SPIO SLNB
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. Breast cancer patients aged 20 or above
2. Clinical axillary lymph node negative
3. Written informed concent
Key exclusion criteria 1. Ipsirateral breast tumor reccurrence
2. History of axillary surgery
3. After insertion breast implant
4. Male breast cancer
Target sample size 65

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masujiro Makita
Organization Nippon Medical School Musashikosugi Hospital
Division name Department of breast surgery
Zip code
Address 1-396 Kosugi-machi, Nakahara-ku, Kawasaki-shi, Kanagawa 211-8533, Japan.
TEL 044-733-5181
Email m-makita@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masujiro Makita
Organization Nippon Medical School Musashikosugi Hospital
Division name Department of breast surgery
Zip code
Address 1-396 Kosugi-machi, Nakahara-ku, Kawasaki-shi, Kanagawa 211-8533, Japan.
TEL 044-733-5181
Homepage URL
Email m-makita@nms.ac.jp

Sponsor
Institute Nippon Medical School Musashikosugi Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
SLN detection rate using the new system was 100 per cent. SLN detection rate using RI method was 98.6 per cent.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 02 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 30 Day
Last follow-up date
2018 Year 11 Month 30 Day
Date of closure to data entry
2018 Year 11 Month 30 Day
Date trial data considered complete
2018 Year 11 Month 30 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 10 Month 09 Day
Last modified on
2018 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033678

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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