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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024924
Receipt No. R000028589
Scientific Title efficacy of sentinel node biopsy in oral cancer using 3D-CT lymphography and an indocyanine gree fluorescence guidance
Date of disclosure of the study information 2016/11/22
Last modified on 2019/07/16

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Basic information
Public title efficacy of sentinel node biopsy in oral cancer using 3D-CT lymphography and an indocyanine gree fluorescence guidance
Acronym efficacy of sentinel node biopsy in oral cancer using 3D-CT lymphography and an indocyanine gree fluorescence guidance
Scientific Title efficacy of sentinel node biopsy in oral cancer using 3D-CT lymphography and an indocyanine gree fluorescence guidance
Scientific Title:Acronym efficacy of sentinel node biopsy in oral cancer using 3D-CT lymphography and an indocyanine gree fluorescence guidance
Region
Japan

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

Objectives
Narrative objectives1 We perform to evaluate the efficacy of sentinel lymph node biopsy in oral cancer using 3D-CT lymphography and ICG fluorescence guidance
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification rate of sentinel lymph node by using 3D-CT lymphography and ICG fluorescence guidance
Key secondary outcomes 1.False negative rate of sentinel lymph node
2.Relations between BMI and identification rate of sentinel lymph node

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 We perfomethe sentinel lymph node biopsy in oral cancer patients using 3D-CT lymphography and ICG fluorescence guidance
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 Male and Female
Key inclusion criteria Patients with previously untreated cTxN0M0 oral cancer who was evaluated with clinical examination,ulutrasound,CT,and or MRI,are the canditates for our study.
patient no having in history of previous head and neck cancer,
no allergy to iodne,shelfish and ICG
Key exclusion criteria A history of radiation therapy to neck,prior head and neck cancer
Pregnacy or lactating women ,or women with suspected pregnancy
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Osamu
Middle name
Last name Ishihara
Organization Osaka General Medical Center
Division name Oral & Maxillofacial Surgery
Zip code 5888558
Address 1-56,Bandaihigashi 3-chome, Sumiyoshi-ku,Osaka
TEL 06-6692-1201
Email ishihara@gh.opho.jp

Public contact
Name of contact person
1st name Osamu
Middle name
Last name Ishihara
Organization Osaka General Medical Center
Division name Oral & Maxillofacial Surgery
Zip code 558-8558
Address 1-56,Bandaihigashi 3-chome, Sumiyoshi-ku,Osaka
TEL 06-6692-1201
Homepage URL
Email ishihara@gh.opho.jp

Sponsor
Institute Osaka General Medical Center
Institute
Department

Funding Source
Organization None
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 osaka general medhical center
Address 1-56,Bandaihigashi 3-chome, Sumiyoshi-ku,Osaka
Tel 06-6692-1201
Email kenkyushien@gh.opho.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 大阪急性期・総合医療センター

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 22 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 09 Month 14 Day
Date of IRB
2016 Year 09 Month 14 Day
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2026 Year 09 Month 01 Day
Date of closure to data entry
2026 Year 09 Month 01 Day
Date trial data considered complete
2026 Year 09 Month 01 Day
Date analysis concluded
2026 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 21 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028589

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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