UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030127 |
|---|---|
| Receipt number | R000034387 |
| Scientific Title | Sentinel lymph node biopsy in patients with breast cancer using superparamagnetic iron oxide and a magnetometer. |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2017/11/27 07:12:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Sentinel lymph node biopsy in patients with breast cancer using superparamagnetic iron oxide and a magnetometer.
Acronym
Sentinel lymph node biopsy in breast cancer using SPIO
Scientific Title
Sentinel lymph node biopsy in patients with breast cancer using superparamagnetic iron oxide and a magnetometer.
Scientific Title:Acronym
Sentinel lymph node biopsy in breast cancer using SPIO
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This is a study to validate using a magnetic tracer to identify sentinel lymph nodes in patients with breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess rate of identification, sensitivity and false negative in this procedure
Key secondary outcomes
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Superparamagnetic iron oxide and patent blue dye were injected in the subareolar breast tissue. Following a few minutes of massage to promote migration of iron tracer and blue dye throughout the lymphatic vessels, axillary lymph nodes were detected transdermally using a handheld magnetometer and followed by standard axillary dissection in all patients.
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
patients with clinically node-negative breast cancer
Key exclusion criteria
clinically node-positive patients
patients received preoperative chemotherapy
male breast cancer
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikio Shiozawa |
Organization
Oyama Municipal Hospital
Division name
Department of Surgery
Zip code
Address
2251 Hitotonoya, Oyama, Tochigi, Japan
TEL
0285360200
shiozawa@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikio Shiozawa |
Organization
Jichi Medical University
Division name
Department of Surgery
Zip code
Address
Yakushiji 3311-1, Shimotsuke City Tochigi Japan
TEL
0285587371
Homepage URL
shiozawa@jichi.ac.jp
Sponsor or person
Institute
Oyama Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Oyama Municipal Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 01 | 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
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
Main results already published
Date of protocol fixation
| 2008 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 27 | Day |
Last modified on
| 2017 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034387
