UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011705 |
|---|---|
| Receipt number | R000013687 |
| Scientific Title | Study of Hepatocellular Carcinoma Detection Capability, Exposure Reduction Effect, and Contrast Dose of Low Tube Voltage CT with Iterative Reconstruction in Patients with Chronic Liver Disease |
| Date of disclosure of the study information | 2013/09/20 |
| Last modified on | 2013/09/11 10:55:51 |
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Basic information
Public title
Study of Hepatocellular Carcinoma Detection Capability, Exposure Reduction Effect, and Contrast Dose of Low Tube Voltage CT with Iterative Reconstruction in Patients with Chronic Liver Disease
Acronym
Study of HCC Detection Capability, Exposure Reduction Effect, and Contrast Dose of Low Tube Voltage CT with Iterative Reconstruction
Scientific Title
Study of Hepatocellular Carcinoma Detection Capability, Exposure Reduction Effect, and Contrast Dose of Low Tube Voltage CT with Iterative Reconstruction in Patients with Chronic Liver Disease
Scientific Title:Acronym
Study of HCC Detection Capability, Exposure Reduction Effect, and Contrast Dose of Low Tube Voltage CT with Iterative Reconstruction
Region
| Japan |
Condition
Condition
hepatic carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The study is conducted with an aim to examine the effect of reduced X-ray exposure and the dose of contrast medium by low-voltage CT imaging with IR (80kVp) on the ability to detect the lesion of hypervascular hepatocellular carcinoma
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ability to detect hypervascular hepatocellular carcinoma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
The patients for whom multi-phase hepatographic CT is performed to diagnose hepatocellular carcinoma will be randomly allocated to the following protocol groups: (1) 120 kVp; SD(noise index) 10, 600 mgI/kg; Without IR (control group)
Interventions/Control_2
(2) With IR, 80 kVp; SD 10; 370 mgI/kg
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
1, Patients with chronic liver disease
2, Patients suspected of hepatocellular 3, carcinoma
4, Body weight of 65 kg or lower
5, Both inpatients and outpatients
6, Both men and women
7, Patients aged 20 years or older
Patients who had been provided with ample explanation before participating in this clinical study, fully understood the content of the study, and submitted a written consent to voluntarily participate in the study
Key exclusion criteria
1, Lesions with a size of 2 cm or smaller
2, Patient who have over 5 lesions
3, According to "Contraindications and relative contraindications of contrast media in study patients"
4, Pregnant or lactating women
5, Patients for whom the investigator or subinvestigator(s) judges their participation in the clinical trial to be inappropriate
Target sample size
340
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Ichikawa |
Organization
University of Yamanashi hospital
Division name
Department of Radiology
Zip code
Address
1110, Shimogato, Chuo, Yamanashi, 409-3898
TEL
055-273-1111
ichikawa@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Ichikawa |
Organization
University of Yamanashi hospital
Division name
Department of Radiology
Zip code
Address
1110, Shimogato, Chuo, Yamanashi, 409-3898
TEL
055-273-1111
Homepage URL
ichikawa@yamanashi.ac.jp
Sponsor or person
Institute
Department of Radiology doctors' office, University of Yamanashi hospital
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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 | 09 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2014 | 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
| 2013 | Year | 09 | Month | 11 | Day |
Last modified on
| 2013 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013687
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| Registered date | File name |
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| Registered date | File name |
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