UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036278 |
|---|---|
| Receipt number | 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 18:12:02 |
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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
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
y-noto@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041321
