UMIN-CTR Clinical Trial

Basic information
Public title	Diagnosis, severity assessment, and therapy evaluation of amyloidosis using amyloid PET imaiging (Continued study from 2020)
Acronym	Diagnosis, severity assessment, and therapy evaluation of amyloidosis using amyloid PET imaiging (Continued study from 2020)
Scientific Title	Diagnosis, severity assessment, and therapy evaluation of amyloidosis using amyloid PET imaiging (Continued study from 2020)
Scientific Title:Acronym	Diagnosis, severity assessment, and therapy evaluation of amyloidosis using amyloid PET imaiging (Continued study from 2020)
Region	Japan

Condition
Condition	amyloidosis
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of amyloid PET imaging in severity assessment and therapy evaluation of amyloidosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intensity of 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	Amyloid PET examination is perfomed when diagnosis of amyloidosis is made. Patient who recieves treatment intervention requires sequential amyloid PET examinations after starting 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	Any adult participant who is diagnosed as having amyloidosis.
Key exclusion criteria	Participant who doesn't agree to enroll the study.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yoshiki Middle name Last name Sekijima
Organization	Shinshu University School of Medicine
Division name	Department of Medicine (Neurology and Rheumatology)
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263-37-2673
Email	sekijima@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Nagaaki Middle name Last name Katoh
Organization	Shinshu University School of Medicine
Division name	Department of Medicine (Neurology and Rheumatology)
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263-37-2673
Homepage URL
Email	nagaaki@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	Aizawa hospital
Name of secondary funder(s)	Alnylam corp.

IRB Contact (For public release)
Organization	Ethics Committee of Shinshu University School of Medicine
Address	3-1-1 Asahi, 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

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 19 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
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	2020 Year 09 Month 08 Day
Date of IRB	2020 Year 09 Month 08 Day
Anticipated trial start date	2020 Year 09 Month 08 Day
Last follow-up date	2025 Year 08 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	2020 Year 10 Month 19 Day
Last modified on	2020 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048136