UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045294 |
|---|---|
| Receipt number | R000051733 |
| Scientific Title | Multimodality fusion of Autoregistration-loaded Realtime virtual sonography with CT images |
| Date of disclosure of the study information | 2021/08/29 |
| Last modified on | 2021/08/29 09:50:06 |
* 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
Multimodality fusion of Autoregistration-loaded Realtime virtual sonography with CT images
Acronym
MARC-01 Study
Scientific Title
Multimodality fusion of Autoregistration-loaded Realtime virtual sonography with CT images
Scientific Title:Acronym
MARC-01 Study
Region
| Japan |
Condition
Condition
Liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Validation study of RVS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in recognition of small target in liver
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
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
RVS
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 who have
1) required to recognize small liver tumors (1cm or smaller) or 3rd or more peripheral branches of portal veins
2)are scheduled to undergo laparotomy
Key exclusion criteria
1)not available of preoperative CT images
2)post right of left hepatectomy
3)involvement of portal bifurcation
4)having a cardiac pacing device
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | Takamoto |
| Last name | Takamoto |
Organization
National Cancer Center Hospital
Division name
Hepatibilliary Pancreatic Surgery
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
takamoto@nifty.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Takamoto |
Organization
Hepatibilliary Pancreatic Surgery
Division name
Hepatibilliary Pancreatic Surgery
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
Homepage URL
takamoto@nifty.com
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
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
National Cancer Center Hospital
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel
0335422511
takamoto@nifty.com
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
| 2021 | Year | 08 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 29 | Day |
Last modified on
| 2021 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051733
