UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023993 |
|---|---|
| Receipt number | R000027618 |
| Scientific Title | Tumor identification using fluorescence imaging: comparison of two imaging systems |
| Date of disclosure of the study information | 2016/09/18 |
| Last modified on | 2025/01/08 13:40:33 |
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Basic information
Public title
Tumor identification using fluorescence imaging: comparison of two imaging systems
Acronym
Tumor identification using fluorescence imaging: comparison of two imaging systems
Scientific Title
Tumor identification using fluorescence imaging: comparison of two imaging systems
Scientific Title:Acronym
Tumor identification using fluorescence imaging: comparison of two imaging systems
Region
| Japan |
Condition
Condition
liver cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It has been frequently reported the effectiveness of ICG fluorescence imaging in liver cancer, including Hepatocellular carcinoma. However there is still no consciousness in recognition rate by ICG dose and each systems. The difference of tumor recognition rate between two different systems and ICG dosages were investigated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tumor recognition rate between two imaging systems
Key secondary outcomes
Tumor recognition rate in the ICG dosages
Tumor recognition rate of each tumors
Tumor recognition rate in the tumor diameter and location of tumors
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Indocyanine Green
Interventions/Control_2
ICG fluorescence imaging systems
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diseases require liver resection
Key exclusion criteria
History of the hypersensitivity to ICG
Iodine allergy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Norihiro |
| Middle name | |
| Last name | Kokudo |
Organization
Graduate school of medicine, University of Tokyo
Division name
Hepato-Biliary-Pancreas Surgery Division, Department of
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
KOKUDO-2SU@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Kobayashi |
Organization
Graduate school of medicine, University of Tokyo
Division name
Hepato-Biliary-Pancreas Surgery Division, Department of
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
kobayashik-sur@h.u-tokyo.ac.jp
Sponsor or person
Institute
Graduate school of medicine, University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Graduate school of medicine, 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
IRB, Graduate school of medicine, University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5800-8743
crescent-office@umin.net
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
| 2016 | Year | 09 | Month | 18 | 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 | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | 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
| 2016 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027618
