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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025426
Receipt No. R000029268
Scientific Title Setinel lymph node biopsy using superparamagnetic iron oxide and magnetic probe for oral cancer patients
Date of disclosure of the study information 2016/12/27
Last modified on 2019/07/06

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Basic information
Public title Setinel lymph node biopsy using superparamagnetic iron oxide and magnetic probe for oral cancer patients
Acronym SLNB using magnetic probe for oral cancer
Scientific Title Setinel lymph node biopsy using superparamagnetic iron oxide and magnetic probe for oral cancer patients
Scientific Title:Acronym SLNB using magnetic probe for oral cancer
Region
Japan

Condition
Condition Oral cancer
Classification by specialty
Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate uttility of sentinel lymph node
biopsy using superparamagnetic iron oxide and magnetic probe for oral cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Identification and biopsy of sentinel lymph node
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
Medicine Device,equipment
Interventions/Control_1 Superparamagnetic iron oxide (0.4-1.2 ml)is injected around oral cancer 1 day before surgery, and sentinel lympho node mappling is performed using MR lymphography.
During surgery, sentinel lymph node biopsy is performed using magnetic probe.
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
100 years-old >
Gender Male and Female
Key inclusion criteria Early stage oral cancer patients without cervical lymph node metastasis (T1-2N0).
Untreated oral cancer patients.
Key exclusion criteria Patients with allergy of iron or iodine agent, pregnacy, asthma, or renal dysfunction.
Target sample size 27

Research contact person
Name of lead principal investigator
1st name Toshinori
Middle name
Last name Iwai
Organization Yokohama City University Hospital
Division name Department of Oral and Maxillofacial Surgery/Orthodontics
Zip code 236-0004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004
TEL +819030021548
Email iwai104oams@yahoo.co.jp

Public contact
Name of contact person
1st name Toshinori
Middle name
Last name Iwai
Organization Yokohama City University Hospital
Division name Department of Oral and Maxillofacial Surgery/Orthodontics
Zip code 236-0004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004
TEL +819030021548
Homepage URL
Email iwai104oams@yahoo.co.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Funding Source
Organization Yokohama City University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Yokohama City University Certified Institutional Review Board
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
Tel 045-787-2800
Email ycu_crb@yokohama-cu.ac.jp

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
2016 Year 12 Month 27 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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 27 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
2016 Year 12 Month 27 Day
Last modified on
2019 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029268

Research Plan
Registered date File name
2018/07/02 02_計画書.docx

Research case data specifications
Registered date File name
2018/07/02 MRLG dataシート.xlsx

Research case data
Registered date File name
2018/07/02 MRLG dataシート.xlsx


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