UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024924
Receipt number R000028589
Scientific Title efficacy of sentinel node biopsy in oral cancer using 3D-CT lymphography and an indocyanine gree fluorescence guidance
Date of disclosure of the study information 2016/11/22
Last modified on 2023/12/05 15:16:13

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Basic information

Public title

efficacy of sentinel node biopsy in oral cancer using 3D-CT lymphography and an indocyanine gree fluorescence guidance

Acronym

efficacy of sentinel node biopsy in oral cancer using 3D-CT lymphography and an indocyanine gree fluorescence guidance

Scientific Title

efficacy of sentinel node biopsy in oral cancer using 3D-CT lymphography and an indocyanine gree fluorescence guidance

Scientific Title:Acronym

efficacy of sentinel node biopsy in oral cancer using 3D-CT lymphography and an indocyanine gree fluorescence guidance

Region

Japan


Condition

Condition

Oral cancer

Classification by specialty

Oral surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We perform to evaluate the efficacy of sentinel lymph node biopsy in oral cancer using 3D-CT lymphography and ICG fluorescence guidance

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Identification rate of sentinel lymph node by using 3D-CT lymphography and ICG fluorescence guidance

Key secondary outcomes

1.False negative rate of sentinel lymph node
2.Relations between BMI and identification rate of sentinel lymph node


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

Maneuver

Interventions/Control_1

We perfomethe sentinel lymph node biopsy in oral cancer patients using 3D-CT lymphography and ICG fluorescence guidance

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 with previously untreated cTxN0M0 oral cancer who was evaluated with clinical examination,ulutrasound,CT,and or MRI,are the canditates for our study.
patient no having in history of previous head and neck cancer,
no allergy to iodne,shelfish and ICG

Key exclusion criteria

A history of radiation therapy to neck,prior head and neck cancer
Pregnacy or lactating women ,or women with suspected pregnancy

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Osamu
Middle name
Last name Ishihara

Organization

Osaka General Medical Center

Division name

Oral & Maxillofacial Surgery

Zip code

5888558

Address

1-56,Bandaihigashi 3-chome, Sumiyoshi-ku,Osaka

TEL

06-6692-1201

Email

ishihara@gh.opho.jp


Public contact

Name of contact person

1st name Osamu
Middle name
Last name Ishihara

Organization

Osaka General Medical Center

Division name

Oral & Maxillofacial Surgery

Zip code

558-8558

Address

1-56,Bandaihigashi 3-chome, Sumiyoshi-ku,Osaka

TEL

06-6692-1201

Homepage URL


Email

ishihara@gh.opho.jp


Sponsor or person

Institute

Osaka General Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

osaka general medhical center

Address

1-56,Bandaihigashi 3-chome, Sumiyoshi-ku,Osaka

Tel

06-6692-1201

Email

kenkyu-crb@gh.opho.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

大阪急性期・総合医療センター


Other administrative information

Date of disclosure of the study information

2016 Year 11 Month 22 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

Completed

Date of protocol fixation

2016 Year 09 Month 14 Day

Date of IRB

2016 Year 09 Month 14 Day

Anticipated trial start date

2016 Year 11 Month 01 Day

Last follow-up date

2026 Year 09 Month 01 Day

Date of closure to data entry

2026 Year 09 Month 01 Day

Date trial data considered complete

2026 Year 09 Month 01 Day

Date analysis concluded

2026 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2016 Year 11 Month 21 Day

Last modified on

2023 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028589


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name