UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006509 |
|---|---|
| Receipt number | R000007723 |
| 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. |
| Date of disclosure of the study information | 2011/10/12 |
| Last modified on | 2019/06/25 17:17:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hasegawa@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007723
