UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012319 |
|---|---|
| Receipt number | R000014405 |
| Scientific Title | Imaging of systemic amyloidosis with 99mTc-aprotinin |
| Date of disclosure of the study information | 2013/11/25 |
| Last modified on | 2019/03/18 19:24:00 |
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Basic information
Public title
Imaging of systemic amyloidosis with 99mTc-aprotinin
Acronym
Aprotinin scintigraphy
Scientific Title
Imaging of systemic amyloidosis with 99mTc-aprotinin
Scientific Title:Acronym
Aprotinin scintigraphy
Region
| Japan |
Condition
Condition
Cardiac amyloidosis
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Pneumology | Endocrinology and Metabolism | Hematology and clinical oncology |
| Neurology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the diagnostic utility of 99mTc aprotinin scintigraphy for the detection of cardiac amyloidosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive predictive value
Key secondary outcomes
Sensitivity
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
| Medicine |
Interventions/Control_1
Whole-body and cross sectional images will be obtained using a SPECT camera 90min after injection of 740MBq of 99mTc-aprotinin.Biopsy will be planned for the positive patients to confirm the image diagnosis.
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 suspected of systemic amyloidosis and of cardiac amyloidosis, and those who have signed the informed consent form. This study includes all types of amyloidosis such as familial, AL or AA types.
Key exclusion criteria
Those who have not signed the informed consent form.
Those who have serious underlying disease prone to have liver, kidney or metabolic dysfunction.
Those who have been decided not appropriate by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ryogo |
| Middle name | |
| Last name | Minamimoto |
Organization
National Center for Global Health and Medicine
Division name
Div.Nuclear Medicine, Dept.Radiology
Zip code
162-8655
Address
1-21-1 Shinjuku-ku Tokyo, 162-8655 Japan
TEL
03-3202-7181
rminamimoto@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Ryogo |
| Middle name | |
| Last name | Minamimoto |
Organization
NCGM
Division name
Div.Nuclear Medicine, Dept.Radiology
Zip code
1628655
Address
1-21-1 Shinjuku-ku Tokyo, 162-8655 Japan
TEL
03-3202-7181
Homepage URL
ryogom@gmail.com
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1, Toyama,Shinjyuku-ku
Tel
03-3202-7181
ryogom@gmail.com
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
| 2013 | Year | 11 | Month | 25 | 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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2010 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2013 | Year | 11 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014405
