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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019734
Receipt No. R000022792
Scientific Title Diagnosis, staging, and evaluation of treatment response in patients with amyloidosis using amyloid PET imaging
Date of disclosure of the study information 2015/11/10
Last modified on 2019/11/13

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Basic information
Public title Diagnosis, staging, and evaluation of treatment response in patients with amyloidosis using amyloid PET imaging
Acronym Amyloid deposits detection using amyloid PET
Scientific Title Diagnosis, staging, and evaluation of treatment response in patients with amyloidosis using amyloid PET imaging
Scientific Title:Acronym Amyloid deposits detection using amyloid PET
Region
Japan

Condition
Condition amyloidosis
Classification by specialty
Medicine in general Hematology and clinical oncology Neurology
Clinical immunology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to improve the prognosis of amyloidosis, early diagnosis and appropriate evaluation of severity and treatment response are needed. The aim of this study is to investigate the efficacy of amyloid PET imaging for diagnosis and evaluation of this disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Degree of PET tracer uptake in each organ
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 At the time of diagnosis of amyloidosis, amyloid PET scan is performed. In the case whose amyloidosis is treatable situation, amyloid PET scan will be performed again after initiating or completing the treatment.
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 1. Adult patients who are diagnosed as any type of amyloidosis
2. Patients who can provide written informed consent
Key exclusion criteria 1. Patients who cannot provide consent
2. Any patients who are considered ineligible by study manager
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yoshiki
Middle name
Last name Sekijima
Organization Shinshu University
Division name Department of Medicine (Neurology and Rheumatology)
Zip code 390-8621
Address Asahi 3-1-1, Matsumoto, Nagano, Japan
TEL +81-263-37-2673
Email sekijima@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Nagaaki
Middle name
Last name Katoh
Organization Shinshu University
Division name Department of Medicine (Neurology and Rheumatology)
Zip code 390-8621
Address Asahi 3-1-1, Matsumoto, Nagano, Japan
TEL +81-263-37-2673
Homepage URL
Email nagaaki@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Pfizer, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Shinshu University IRB
Address Asahi 3-1-1, Matsumoto, Nagano
Tel 0263-37-2572
Email mdrinri@shinshu-u.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 信州大学医学部附属病院(長野県)/ Shinshu University (Nagano)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
Date of protocol fixation
2015 Year 11 Month 04 Day
Date of IRB
2015 Year 11 Month 04 Day
Anticipated trial start date
2015 Year 11 Month 10 Day
Last follow-up date
2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 10 Day
Last modified on
2019 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022792

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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