UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000041321