UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000022792