UMIN-CTR Clinical Trial

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
Email	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
Email	my-takasu@syd.odn.ne.jp

Sponsor
Institute	Department of Diagnostic Radiology, Graduate School of Biomedical Sciences, Hiroshima University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004405