UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025426 |
|---|---|
| Receipt number | 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 | 2020/06/30 14:48:06 |
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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
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
iwai104oams@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2016 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 04 | Day |
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
| 2020 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.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 |
