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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007891
Receipt No. R000009297
Scientific Title Evaluation of navigation surgery in head and neck cancer with ICG near-infrared fluorescence imaging.
Date of disclosure of the study information 2012/05/07
Last modified on 2013/03/21

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Basic information
Public title Evaluation of navigation surgery in head and neck cancer with ICG near-infrared fluorescence imaging.
Acronym Evaluation of navigation surgery in head and neck cancer with ICG near-infrared fluorescence imaging.
Scientific Title Evaluation of navigation surgery in head and neck cancer with ICG near-infrared fluorescence imaging.
Scientific Title:Acronym Evaluation of navigation surgery in head and neck cancer with ICG near-infrared fluorescence imaging.
Region
Japan

Condition
Condition oral and oropharyngeal cancer
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficacy of tumor optical imaging by intraoperative ICG near-infrared fluorescence in head and neck cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Specific accumulation of ICG in head and neck tumor.
efficacy of ICG near-infrared fluorescence imaging in tumor resection.
Key secondary outcomes 1.evaluation of surgical margin.
2.minimum invasive surgery and function preservation.
3.survival rate

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 Maneuver
Interventions/Control_1 Iintravenous adminstration of ICG.
Identification of limit of invasion with intraoperative ICG near-infrared fluorescence imaging.
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 1.Patient age 20 years and above
2.The lesion nsked in neck or oral and pharynx
3.Patients who are planned radical surgery for primary site.
4. Patients who were provided written informed consent
Key exclusion criteria 1.Pregnancy or lactating women or women with suspected pregnancy
2.Patients having past history of hypersensitivity to iodine
3.Patient judged by the investigator to be unfit to be enrolled into the study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junkichi Yokoyama
Organization Juntendo university school of medicine
Division name Department of Otolaryngology, head and neck surgery
Zip code
Address 2-1-2, Hongo, Bunkyou-ku, Tokyo
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo university school of medicine
Division name Department of Otolaryngology, head and neck surgery
Zip code
Address
TEL 03-3813-3111
Homepage URL
Email

Sponsor
Institute Juntendo university school of medicine
Institute
Department

Funding Source
Organization Health and Labor Science Reserch Grant for Clinical Cancer Reserch
Organization
Division
Category of Funding Organization
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
2012 Year 05 Month 07 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 Preinitiation
Date of protocol fixation
2012 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 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
2012 Year 05 Month 05 Day
Last modified on
2013 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009297

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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