UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of clinical efficacy and safety of sentinel lymph node biopsy using magnetic nanoparticle and magnetic probe
Title of the study (Brief title)	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	Hiroyuki Takei
Organization	Nippon Medical School Hospital
Division name	Department of Breast Surgery
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	takei-hiroyuki@nms.ac.jp

Public contact
Name of contact person	Tomoko Kurita
Organization	Nippon Medical School Hospital
Division name	Department of Breast Surgery
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	tomoko28@nms.ac.jp

Sponsor
Institute	Japan Agency for Medical Research and Development
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	Nippon Medical School Showa University
Name of secondary funｄer(s)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 10 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035463