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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024381
Receipt No. R000028068
Scientific Title Utility of Difussion Kurtosis Imaging for Differentiation of Benign and Malignant Musculoskeletal Lesions
Date of disclosure of the study information 2016/11/01
Last modified on 2017/10/13

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Basic information
Public title Utility of Difussion Kurtosis Imaging for Differentiation of Benign and Malignant Musculoskeletal Lesions
Acronym Utility of DKI for Diffrentiation of Musculoskeletal Lesions
Scientific Title Utility of Difussion Kurtosis Imaging for Differentiation of Benign and Malignant Musculoskeletal Lesions
Scientific Title:Acronym Utility of DKI for Diffrentiation of Musculoskeletal Lesions
Region
Japan

Condition
Condition musculoskeletal lesion
Classification by specialty
Orthopedics Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess whether diffusion kurtosis imaging (DKI) is usuful for differentiation of benign and malignant musculoskeletal lesions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We scan diffusion kurtosis imaging (DKI) for about 40 patients with benign/malignant musculoskeletal lesions, and we perform statistical analysis for examination whether mean kurtosis or ADC is useful for differentiation.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Osteolytic lesions or soft tissue lesions.
Size > 2cm.
Before operation or radiation therapy.
Key exclusion criteria Younger than 18 years.
Contraindications to MRI (incompatible metal implants or pacemakers).
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Ogawa
Organization Nagoya City University Graduate School of Medical Science.
Division name Radiology
Zip code
Address 1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-ci, Aichi
TEL +81-52-853-8276
Email eternal@fj9.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ogawa Masaki
Organization Nagoya City University Graduate School of Medical Science.
Division name Radiology
Zip code
Address 1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-ci, Aichi
TEL +81-52-853-8276
Homepage URL
Email eternal@fj9.so-net.ne.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Science.
Radiology.
Institute
Department

Funding Source
Organization Self funding
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
Email

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
2016 Year 11 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
MK showed a strong correction with ADC (Spearman rs=0.95). Both MK and ADC values show significant differences between benign and malignant lesions (p<0.01). The area under the curve was 0.98 and 1.00 for MK and ADC, with no differences (p=0.37).
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
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
2017 Year 08 Month 31 Day
Date trial data considered complete
2017 Year 08 Month 31 Day
Date analysis concluded
2017 Year 08 Month 31 Day

Other
Other related information no data

Management information
Registered date
2016 Year 10 Month 12 Day
Last modified on
2017 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028068

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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