UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031240 |
|---|---|
| Receipt number | R000035463 |
| Scientific Title | Evaluation of clinical efficacy and safety of sentinel lymph node biopsy using magnetic nanoparticle and magnetic probe |
| Date of disclosure of the study information | 2018/02/09 |
| Last modified on | 2018/02/09 22:36:02 |
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Basic information
Public title
Evaluation of clinical efficacy and safety of sentinel lymph node biopsy using magnetic nanoparticle and magnetic probe
Acronym
Evaluation of clinical efficacy and safety of sentinel lymph node biopsy using magnetic nanoparticle and magnetic probe
Scientific Title
Evaluation of clinical efficacy and safety of sentinel lymph node biopsy using magnetic nanoparticle and magnetic probe
Scientific Title:Acronym
Evaluation of clinical efficacy and safety of sentinel lymph node biopsy using magnetic nanoparticle and magnetic probe
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is, using super paramagnetic iron oxide (SPIO)/magnetic probe system model, to demonstrate non-inferiority of SPIO/magnetic probe system compared with an isotope technique for SNB in patients with breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification rate
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
On the day before surgery or in the morning of the operation day, 1ml a superparamagnetic iron oxide (SPIO) contrast agent are injected on the same side of breast cancer in subcutaneous areola. All sentinel lymph nodes detected intraoperatively by using the magnetic probe system model or gamma probe or nodes that were blue or brown, were excised. Sentinel lymph nodes are evaluated the status of node metastasis and iron-staining.
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
Primary breast cancer with clinical no lymph node metastasis
Key exclusion criteria
1. Breast cancer recurrence
2. Who had a history of operation of Axilla
3. Post operative status of augmentation mammaplasty
4. Male breast cancer
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Takei |
Organization
Nippon Medical School Hospital
Division name
Department of Breast Surgery
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
takei-hiroyuki@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Kurita |
Organization
Nippon Medical School Hospital
Division name
Department of Breast Surgery
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
tomoko28@nms.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
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
Nippon Medical School
Showa University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
日本医科大学（東京都）、昭和大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 09 | Day |
Last modified on
| 2018 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035463
