UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010026 |
|---|---|
| Receipt number | R000011739 |
| Scientific Title | Abdominal CT Studies for Newly-Developed Scan and Contrast EnhancementTechniques and Image Analysis Methods |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2013/02/13 17:44:41 |
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Basic information
Public title
Abdominal CT Studies for Newly-Developed Scan and Contrast EnhancementTechniques and Image Analysis Methods
Acronym
Abdominal CT Studies for Newly-Developed Scan and Contrast EnhancementTechniques and Image Analysis Methods
Scientific Title
Abdominal CT Studies for Newly-Developed Scan and Contrast EnhancementTechniques and Image Analysis Methods
Scientific Title:Acronym
Abdominal CT Studies for Newly-Developed Scan and Contrast EnhancementTechniques and Image Analysis Methods
Region
| Japan |
Condition
Condition
Abdominal diseases
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess various newly-developed abdominal CT divices and techniques such as area-detector, dual X-ray tube, high-speed shuttle scan, gastro- and colonography, and perfusion scan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Readers' subjective assessmentof CT images including image contrast, tumor detection ability, and vessel visualization
Objective CT image noise, image contrast, tumor detection ability
Comparison with organ perfusion parameters or iodine concentration and other clinical findings
Comparison with findings on CT gasrto/olonography and other clinical findings
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
9
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
Area-detector scan
Interventions/Control_2
Dual X-ray tube scan
Interventions/Control_3
High-speed helical shuttle
Interventions/Control_4
respiratory triggered scan
Interventions/Control_5
CT gasrtography and colonography
Interventions/Control_6
Determination of substance in the body
Interventions/Control_7
Organ perfusion measurement
Interventions/Control_8
Dose reduction of contrastmedium
Interventions/Control_9
Dose reduction of irradiation
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult (20 years old or elder) patients who have or are suspeced to have abdominal diseases underwent or will undergo abdominal CT examination in our institution
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yoshikawa |
Organization
Kobe University Graduate School of Medicine
Division name
Advanced Biomedical Imaging Research Center/Department of Radiology
Zip code
Address
7-5-2 Kusunokicho Chuoku, Kobe, Hyogo 650-0017 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Graduate School of Medicine
Division name
Advanced Biomedical Imaging Research Center/Department of Radiology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine
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 | 05 | Month | 01 | 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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | 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 | 02 | Month | 13 | Day |
Last modified on
| 2013 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011739
