UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010054 |
|---|---|
| Receipt number | R000011773 |
| Scientific Title | Optimal Method of Injecting a Contrast Medium for CT Urography |
| Date of disclosure of the study information | 2013/02/18 |
| Last modified on | 2022/02/13 10:27:23 |
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Basic information
Public title
Optimal Method of Injecting a Contrast Medium for CT Urography
Acronym
Optimal Method of Injecting a Contrast Medium for CT Urography
Scientific Title
Optimal Method of Injecting a Contrast Medium for CT Urography
Scientific Title:Acronym
Optimal Method of Injecting a Contrast Medium for CT Urography
Region
| Japan |
Condition
Condition
Urothelial tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to reveal the appropriate technique for CT Urography by comparing the image quality provided with split-bolus and single-bolus techniques. The required dose of contrast medium will also investigate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Image quality of renal parenchyma in nephrographic or nephrographic-excretory phase
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Single Bolus method
Interventions/Control_2
Split Bolus method
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 diagnosed urinary tract tumor or suspected urinary tract tumor
Key exclusion criteria
Allergy to Iodinated contrast media, Severe thyroid disease, Pregnancy and lactation
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Takahashi |
Organization
Kobe University
Division name
Radiology
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, 650-0017, JAPAN
TEL
078-382-6104
staka@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Takahashi |
Organization
Kobe University
Division name
Department of Radiology
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, 650-0017, JAPAN
TEL
078-382-6104
Homepage URL
staka@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University, Department of Radiology
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Radiology, Kobe University
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, 650-0017, JAPAN
Tel
078-382-6104
staka@med.kobe-u.ac.jp
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 | 02 | Month | 18 | 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
| 2013 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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 | 16 | Day |
Last modified on
| 2022 | 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=R000011773
