UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011522 |
|---|---|
| Receipt number | R000012498 |
| Scientific Title | Hepatic CT perfusion CT for the therapeutic response of sorafenib for hepatocellular carcinoma |
| Date of disclosure of the study information | 2013/08/19 |
| Last modified on | 2018/08/23 09:32:27 |
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Basic information
Public title
Hepatic CT perfusion CT for the therapeutic response of sorafenib for hepatocellular carcinoma
Acronym
Hepatic CT perfusion CT for the therapeutic response of sorafenib for hepatocellular carcinoma
Scientific Title
Hepatic CT perfusion CT for the therapeutic response of sorafenib for hepatocellular carcinoma
Scientific Title:Acronym
Hepatic CT perfusion CT for the therapeutic response of sorafenib for hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine clinical significance of hepatic CT perfusion for the therapeutic response of sorafenib for hepatocellular carcinoma
Basic objectives2
Others
Basic objectives -Others
To determine clinical utility of hepatic CT perfusion
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine clinical utility of hepatic CT perfusion
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients with hepatocellular carcinoma who are scheduled for sorafenib therapy
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
(a) Patients who are older than 20 year-old
(b) Patients with hepatocellular carcinoma who are scheduled for sorafenib therapy
(c) Patients who weigh less than 100kg
(d) Patients with consent for this study
Key exclusion criteria
(a) Patients who have allergy to CT contrast media
(b) Patients whose performance status is severe
(c) Patients with bronchial asthma
(d) Patients with severe renal dysfunction (eGFR lower than 30ml/min/1.73m2)
(e) Patients who are pregnant or lactating patients
(f) Patients whom doctor in charge has decided to be inappropriate for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Awai |
Organization
Hiroshima University
Division name
Diagnostic Radiology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5257
awai@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Nakamura |
Organization
Hiroshima University
Division name
Diagnostic Radiology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5257
Homepage URL
yukon@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
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
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
| 2013 | Year | 08 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29279169
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
| 2013 | Year | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | 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
| 2013 | Year | 08 | Month | 19 | Day |
Last modified on
| 2018 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012498
