UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026211 |
|---|---|
| Receipt number | R000030111 |
| Scientific Title | Optimal injection method of contrast media in cone-beam CT by dual syringe |
| Date of disclosure of the study information | 2017/02/20 |
| Last modified on | 2023/02/24 09:30:29 |
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Basic information
Public title
Optimal injection method of contrast media in cone-beam CT by dual syringe
Acronym
Optimal injection method in cone-beam CT by dual syringe
Scientific Title
Optimal injection method of contrast media in cone-beam CT by dual syringe
Scientific Title:Acronym
Optimal injection method in cone-beam CT by dual syringe
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the optimal injection methods of contrast media in cone beam CT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification capability of feeding vessel in the tumor
Key secondary outcomes
The degree of artifact, the identification of intra-tumor vessel
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
| Other |
Interventions/Control_1
To compare bi-phase injection with dilution injection for the same patient during angiography via proper hepatic artery or common hepatic artery
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)1-5 Hypervascular hepatocellular carcinoma lesions with a maximum tumor diameter of >= 1.5cm
2)Perfomance status ECOG 0-1
3)serum creatinine within standard value of institution
4)Witten informed consent
Key exclusion criteria
Hypersensitivity to iodinate contrast media
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironao Okubo |
Organization
Juntendo University Nerima Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-1-10 Takanodai, nerima-Ku Tokyo, Japan
TEL
+81-3-5923-3111
drokubo@juntendo-nerima.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironao Okubo |
Organization
Juntendo University Nerima Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-1-10 Takanodai, nerima-Ku Tokyo, Japan
TEL
+81-3-5923-3111
Homepage URL
drokubo@juntendo-nerima.jp
Sponsor or person
Institute
Juntendo University Nerima Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Nerima Hospital, Department of Gastroenterology
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
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
順天堂大学練馬病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 20 | 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 | 10 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2017 | Year | 02 | Month | 19 | Day |
Last modified on
| 2023 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030111
