UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000042312
Receipt No. R000048300
Scientific Title Feasibility study of fluorescence imaging for sentinel lymph node detection using indocyanine green in head and neck cancer.
Date of disclosure of the study information 2020/11/01
Last modified on 2020/11/01 (Ver. 1)

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Basic information
Public title Feasibility study of fluorescence imaging for sentinel lymph node detection using indocyanine green in head and neck cancer.
Acronym Fluorescence imaging for sentinel lymph node detection using ICG in head and neck cancer.
Scientific Title Feasibility study of fluorescence imaging for sentinel lymph node detection using indocyanine green in head and neck cancer.
Scientific Title:Acronym Fluorescence imaging for sentinel lymph node detection using ICG in head and neck cancer.
Region
Japan

Condition
Condition Head and neck cancer
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of fluorescence imaging for sentinel lymph node biopsy using indocyanine green in head and neck cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The detection accuracy of the sentinel lymph nodes
Key secondary outcomes 1. Complications
2. Metastasis of the regional lymph nodes

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 Preoperative local injection of indocyanine green and indigocarmine and intraoperative 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 Patients of head and neck cancer with the indication of elective neck dissection
Key exclusion criteria 1. Recurrent disease
2. Hypersensitivity to indocyanine green or indigocarmine
3. Poorly controlled hypertension
4. Women in pregnancy or breast-feeding
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Shunsuke
Middle name
Last name Miyamoto
Organization Kitasato University School of Medicine
Division name Department of Otorhinolaryngology-Head and Neck Surgery
Zip code 252-0374
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, JAPAN
TEL 042-778-8111
Email s-miya@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Shunsuke
Middle name
Last name Miyamoto
Organization Kitasato University School of Medicine
Division name Department of Otorhinolaryngology-Head and Neck Surgery
Zip code 252-0374
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, JAPAN
TEL 042-778-8111
Homepage URL
Email s-miya@kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine, Department of Otorhinolaryngology-Head and Neck Surgery
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Kitasato University Medical Ethics Organization
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, JAPAN
Tel 042-778-8111
Email rinri-n@kitasato-u.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 北里大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 01 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 8
Results 
 Sentinel lymph nodes were visualized in all eight cases. Two cases showed occult metastases on both sentinel and regional nodes. The identification and false negative rates were 100% and 0%, respectively. There were no complications incurred due to this method.
Results date posted
2020 Year 11 Month 01 Day
Results Delayed
Delay expected
Results Delay Reason Under article submission
Date of the first journal publication of results
Baseline Characteristics 
Seven with tongue cancer and one with tonsil cancer. All were diagnosed with squamous cell carcinoma at stage cT2. The median age of the patients was 63.5 years (range, 50-74 years).
Participant flow 
All participants were monitored for a minimum of five years after the clinical trial.
Adverse events 
Not applicable
Outcome measures 
Efficacy and complications of  sentinel lymph node detection using fluorescence imaging in head and neck cancer
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 08 Month 13 Day
Date of IRB
2012 Year 10 Month 24 Day
Anticipated trial start date
2012 Year 10 Month 24 Day
Last follow-up date
2017 Year 03 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
2020 Year 11 Month 01 Day
Last modified on
2020 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048300