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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026698
Receipt No. R000030652
Scientific Title Detection and evaluation of sentinel lymph nodes and its blood flows with contrast-enhanced ultrasonography in oral cancers -a phase I study-
Date of disclosure of the study information 2017/03/27
Last modified on 2019/05/10

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Basic information
Public title Detection and evaluation of sentinel lymph nodes and its blood flows with contrast-enhanced ultrasonography in oral cancers -a phase I study-
Acronym Detection of sentinel lymph nodes with ultrasonography in oral cancers, a phase I study
Scientific Title Detection and evaluation of sentinel lymph nodes and its blood flows with contrast-enhanced ultrasonography in oral cancers -a phase I study-
Scientific Title:Acronym Detection of sentinel lymph nodes with ultrasonography in oral cancers, a phase I study
Region
Japan

Condition
Condition Oral Cancers
Classification by specialty
Oto-rhino-laryngology Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Feasibility
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety and feasibility of SN SN detection and evaluation of blood flow with contrast enhanced ultrasonography
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 Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Detection of SN and its blood flow with contrast enhanced ultrasonography
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) cNo with CT and/or US
2) No history for treatment of oral cancer
3) 18 years old or older
4) written informed consent
Key exclusion criteria 1) Recurrent cases
2) history of irradiation for neck disease
3) history of treatment before surgery of this time
4) allergy for sonazoid
5) allergy for egg
6) pregnancy
7) Doctors did no approve the continuing the study
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naohiro Wakisaka
Organization Kanazawa University Hospital
Division name Otolaryngology, and Head & Neck Surgery
Zip code
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2413
Email jibiinfo@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohiro Wakisaka
Organization Kanazawa University
Division name Hospital
Zip code
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2413
Homepage URL
Email jibiinfo@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

Funding Source
Organization Kanazawa 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
Address
Tel
Email

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 03 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
Sentinel lymph nodes were detected in six out of seven cases.
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
2017 Year 03 Month 22 Day
Date of IRB
2018 Year 11 Month 28 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2019 Year 05 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Transferred to the other data base

Management information
Registered date
2017 Year 03 Month 25 Day
Last modified on
2019 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030652

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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