UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of Difussion Kurtosis Imaging for Differentiation of Benign and Malignant Musculoskeletal Lesions
Title of the study (Brief title)	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	Masaki Ogawa
Organization	Nagoya City University Graduate School of Medical Science.
Division name	Radiology
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	Ogawa Masaki
Organization	Nagoya City University Graduate School of Medical Science.
Division name	Radiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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).
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/icdr_e/ctr_view.cgi?recptno=R000028068