UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024381 |
|---|---|
| Receipt number | 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 09:44:35 |
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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
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
eternal@fj9.so-net.ne.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Science.
Radiology.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028068
