UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008374 |
|---|---|
| Receipt number | R000009843 |
| Scientific Title | Gadolinium enhanced MR imaging of healthy volunteers using 3Tesla MR: evaluation of contrast material leakage into body fluid |
| Date of disclosure of the study information | 2012/07/07 |
| Last modified on | 2016/09/28 12:11:04 |
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Basic information
Public title
Gadolinium enhanced MR imaging of healthy volunteers using 3Tesla MR: evaluation of contrast material leakage into body fluid
Acronym
Gadolinium enhanced MR imaging of healthy volunteers using 3Tesla MR: evaluation of contrast material leakage into body fluid
Scientific Title
Gadolinium enhanced MR imaging of healthy volunteers using 3Tesla MR: evaluation of contrast material leakage into body fluid
Scientific Title:Acronym
Gadolinium enhanced MR imaging of healthy volunteers using 3Tesla MR: evaluation of contrast material leakage into body fluid
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Gadolinium enhanced MR imaging of body fluid (endolymph fluid, cerebral fluid, and exocrine fluid) in healthy volunteers using 3Tesla MR
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Evaluation for dynamic state of contrast material leakage into body fluid
Key secondary outcomes
Establishment of optimal MR imagimg technique
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
| Medicine |
Interventions/Control_1
Intravenous injection of gadolinium contrast medium (Gd-HP-DO3A)
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
- Healthy individuals who have the ability to provide informed consent
Key exclusion criteria
1. Contraindications to MRI
- A person who has intracorporeal metal such as pacemaker, vascular clip, bolts, and so on.
- A person who is pregnant
- A person who has claustrophobia
2. Contraindications to gadolinium contrast medium
- A person who has an allergy to gadolinium contrast medium
- A person who has bronchial asthma
- Lactating woman
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kojiro Suzuki |
Organization
Nagoya University Hospital
Division name
Department of Radiology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
052-744-2327
kojiro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kojiro Suzuki |
Organization
Nagoya University Hospital
Division name
Department of Radiology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
052-744-2327
Homepage URL
kojiro@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Radiology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 07 | Month | 07 | 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
| 2012 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | 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
| 2012 | Year | 07 | Month | 07 | Day |
Last modified on
| 2016 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009843
