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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036278
Receipt No. R000041321
Scientific Title Amyloid and tau imaging in neuromuscular diseases
Date of disclosure of the study information 2019/04/01
Last modified on 2019/09/23

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Basic information
Public title Amyloid and tau imaging in neuromuscular diseases
Acronym Amyloid- and tau-PET in neuromuscular diseases
Scientific Title Amyloid and tau imaging in neuromuscular diseases
Scientific Title:Acronym Amyloid- and tau-PET in neuromuscular diseases
Region
Japan

Condition
Condition inclusion body myositis, inflammatory myositis, distal myopathy, muscular dystrophy, amyotrophic lateral sclerosis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the utility of muscle PIB- and FDDNP-PET imaging in the diagnosis of neuromuscular diseases
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The distribution pattern of PIB and FDDNP in limb and truncal muscle.
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
Other
Interventions/Control_1 PET imaging
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 with inclusion body myositis, inflammatory myopathy, distal myopathy, muscular dystrophy, amyotrophic lateral sclerosis
Key exclusion criteria Patients accompanied by the disease that affects the main pathogenesis of muscular diseases.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Toshiki
Middle name
Last name Mizuno
Organization Graduate School of Medical Science,
Kyoto Prefectural University of Medicine
Division name Department of Neurology
Zip code 602-8566
Address 465 Kajii-cho, Kamigyo-ku, Kyoto 602-0841, Japan
TEL 075-251-5794
Email mizuno@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Yu-ichi
Middle name
Last name Noto
Organization Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name Department of Neurology
Zip code 602-8566
Address 465 Kajii-cho, Kamigyo-ku, Kyoto 602-0841, Japan
TEL 075-251-5794
Homepage URL
Email y-noto@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kaken-hi
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical committee of Kyoto Prefectural University of Medicine
Address 465 Kajii-cho, Kamigyo-ku, Kyoto 602-0841, Japan
Tel 075-251-5337
Email rinri@koto.kpu-m.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
2019 Year 04 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 13
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
2014 Year 08 Month 29 Day
Date of IRB
2014 Year 10 Month 16 Day
Anticipated trial start date
2014 Year 10 Month 18 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 08 Month 31 Day
Date trial data considered complete
2019 Year 08 Month 31 Day
Date analysis concluded
2019 Year 09 Month 15 Day

Other
Other related information

Management information
Registered date
2019 Year 03 Month 23 Day
Last modified on
2019 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041321

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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