UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019734 |
|---|---|
| Receipt number | 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 20:11:31 |
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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
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
nagaaki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022792
