UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of sentinel lymph node biopsy in oral and laryngo-pharyngeal cancer patients using an indocyanine green fluorescence method and a radioisotope method.
Acronym	Sentinel lymph node biopsy in oral and pharyngo-laryngeal cancer patients using an ICG fluorescence method and a RI method.
Scientific Title	Feasibility study of sentinel lymph node biopsy in oral and laryngo-pharyngeal cancer patients using an indocyanine green fluorescence method and a radioisotope method.
Scientific Title:Acronym	Sentinel lymph node biopsy in oral and pharyngo-laryngeal cancer patients using an ICG fluorescence method and a RI method.
Region	Japan

Condition
Condition	Oral and pharyngo-laryngeal cancer
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to develop a safer method for intraoperative detection of lymph node metastasis in head and neck cancer patients without using a radioisotope method.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	We focus on the accuracy of detecting of sentinel nodes using an ICG fluorescence method.
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	Maneuver
Interventions/Control_1	We perform the sentinel node lymph node biopsy metastasis in head and neck cancer patients using an ICG fluorescence method and a RI method.
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	Previously untreated and clinically negative neck oral (late T2 and T3) and laryngo-pharyngeal (T1-T3) squamous cell carcinoma patients are the candidates for our study.
Key exclusion criteria	1)Previously treated patients 2)A history of radiation therapy for the neck 3)Pregnancy or lactating women, or women with suspected pregnancy
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuhisa Hasegawa
Organization	Aichi Cancer Center
Division name	Department of Head and Neck Surgery
Zip code
Address	1-1 Kanokoden Chikusaku, Nagoya 464-8681, Japan
TEL	052-764-2944
Email	hasegawa@aichi-cc.jp

Public contact
Name of contact person	1st name Middle name Last name Yasuhisa Hasegawa
Organization	Aichi Cancer Center
Division name	Department of Head and Neck Surgery
Zip code
Address	1-1 Kanokoden Chikusaku, Nagoya 464-8681, Japan
TEL	052-762-6111
Homepage URL
Email	hasegawa@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center
Institute
Department

Funding Source
Organization	Health and Labor Sciences Research Grant for Clinical Cancer Research (H21-Gannorinshou-Ippan-016)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	1)Juntendo University School of Medicine
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	2011 Year 10 Month 12 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2011 Year 01 Month 09 Day
Date of IRB	2011 Year 02 Month 18 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date	2015 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 10 Month 10 Day
Last modified on	2019 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007723