UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031546 |
|---|---|
| Receipt number | R000036015 |
| Scientific Title | Indocyanine green fluorescence lymphatic node mapping for gastric cancer |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/09/19 12:27:36 |
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Basic information
Public title
Indocyanine green fluorescence lymphatic node mapping for gastric cancer
Acronym
Indocyanine green fluorescence lymphatic node mapping for gastric cancer
Scientific Title
Indocyanine green fluorescence lymphatic node mapping for gastric cancer
Scientific Title:Acronym
Indocyanine green fluorescence lymphatic node mapping for gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of indocyanine green fluorescence imaging on gastric cancer surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
False negative rate of IGFI on pathological lymph node metastasis
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Lymphatic vessel imaging by indocyanine green 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
Patient receiving gastrectomy at University of Tokyo Hospital, who meets the following criteria
1) Tumor diameter 40mm and smaller
2) age 20 years and older
3) PS(ECOG Performance status) 0 or 1
4) Preserved main organ function
5) Written Informed consent under patients will
Key exclusion criteria
1) Past history of hypersensitivity to indocyanine green
2) Past history of hypersensitivity to iodine
3) Under or with will of pregnancy
4) Nursing
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seto Yasuyuki |
Organization
Graduate school of Medicine, University of Tokyo Hospital
Division name
Gastrointestinal surgery
Zip code
Address
7-3-1, Bunkyou-ku Hongou, Tokyo
TEL
03-3815-5411
seto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iwata Ryohei |
Organization
Graduate school of Medicine, University of Tokyo Hospital
Division name
Gastrointestinal surgery
Zip code
Address
7-3-1, Bunkyou-ku Hongou, Tokyo
TEL
03-3815-5411
Homepage URL
IWATAR-SUR@h.u-tokyo.ac.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
University of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2018 | Year | 04 | 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
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
| 2018 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | 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
| 2018 | Year | 03 | Month | 02 | Day |
Last modified on
| 2018 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036015
