UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003663 |
|---|---|
| Receipt number | R000004405 |
| Scientific Title | Microstructure analysis of trabecular bones in patients with multiple myeloma using 3T-MRI |
| Date of disclosure of the study information | 2010/05/27 |
| Last modified on | 2019/08/03 22:31:25 |
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Basic information
Public title
Microstructure analysis of trabecular bones in patients with multiple myeloma using 3T-MRI
Acronym
Microstructure analysis of trabecular bones in patients
Scientific Title
Microstructure analysis of trabecular bones in patients with multiple myeloma using 3T-MRI
Scientific Title:Acronym
Microstructure analysis of trabecular bones in patients
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of trabecular analysis of the lumbar spine by 3T-MRI to differentiate myeloma patients from normal subjects
Basic objectives2
Others
Basic objectives -Others
Diagnosis of multiple myeloma
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of MRI pattern with myeloma stage
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
MRI examination
-to March 31, 2014
-one exam a year
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
Patients over the age of 20 with MGUS, asymptomatic myeloma, or symptomatic myeloma. Written informed consent is required.
Key exclusion criteria
(a) Patients with pacemaker or foreign body
(b) Patients during pregnancy or with possiblity of pregnancy
(c) Patients who are not considered to be eligible for the test.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Awai |
Organization
Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Diagnostic Radiology
Zip code
734-8551
Address
1-2-3 Kasumi Minamiku Hirosimashi
TEL
0822575257
my-takasu@syd.odn.ne.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Takasu |
Organization
Hiroshima University Hospital
Division name
Department of Diagnostic Radiology
Zip code
734-8551
Address
1-2-3 Kasumi Minamiku Hirosimashi
TEL
082-257-5257
Homepage URL
my-takasu@syd.odn.ne.jp
Sponsor or person
Institute
Department of Diagnostic Radiology, Graduate School of Biomedical Sciences, 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
Institutional Review Board
Address
1-2-3 Kasumi Minamiku Hirosimashi
Tel
082-257-5772
byo-keiei-tiken@office.hiroshima-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
| 2010 | Year | 05 | Month | 27 | 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
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2010 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | 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
| 2010 | Year | 05 | Month | 25 | Day |
Last modified on
| 2019 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004405
