UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057246 |
|---|---|
| Receipt number | R000065434 |
| Scientific Title | Development of a method for early and minimally invasive diagnosis, severity assessment, and treatment response evaluation of cardiac amyloidosis using a hybrid amyloid imaging method combining 18F-Flutemetamol-PET and 99mTc-HMDP scintigraphy |
| Date of disclosure of the study information | 2025/03/10 |
| Last modified on | 2025/03/09 17:38:26 |
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Basic information
Public title
Development of a method for early and minimally invasive diagnosis, severity assessment, and treatment response evaluation of cardiac amyloidosis using a hybrid amyloid imaging method combining 18F-Flutemetamol-PET and 99mTc-HMDP scintigraphy
Acronym
Cardiac amyloidosis research using Vizamyl and Clearborn
Scientific Title
Development of a method for early and minimally invasive diagnosis, severity assessment, and treatment response evaluation of cardiac amyloidosis using a hybrid amyloid imaging method combining 18F-Flutemetamol-PET and 99mTc-HMDP scintigraphy
Scientific Title:Acronym
Cardiac amyloidosis research using Vizamyl and Clearborn
Region
| Japan |
Condition
Condition
Amyloidosis
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the usefulness of hybrid amyloid imaging combining 99mTc-HMDP scintigraphy and 18F-Flutemetamol-PET in early minimally invasive diagnosis, severity assessment, and treatment response assessment of cardiac amyloidosis. As a secondary evaluation, we will also evaluate the ability of these two imaging methods to detect amyloid deposits in organs other than the heart.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The intensity and pattern of cardiac accumulation of two types of tracers (99mTc-HMDP and 18F-Flutemetamol), the relationship between the intensity and clinical parameters, and the time course of the accumulation if positive.
Key secondary outcomes
Detectability of amyloid deposits in organs other than the heart using two imaging methods
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
18F-Flutemetamol-PET and 99mTc-HMDP scintigraphy
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients aged 18 years or older who have been definitively diagnosed with amyloidosis
2.Patients who are able to express their will and have voluntarily agreed to participate in the study, or patients who are unable to express their will and have their proxy consent to participate in the study
Key exclusion criteria
1.Patients with a history of allergies to the study drug
2.Other subjects who the principal investigator deems inappropriate to be subjects
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
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263-37-2673
sannai@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
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263-37-2673
Homepage URL
nagaaki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nihon Medi-Physics Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Life Science and Medical Research Ethics Committee, Shinshu University School of Medicine
Address
Asahi 3-1-1, Matsumoto, Nagano, Japan
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 10 | 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
| 2024 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 12 | 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
| 2025 | Year | 03 | Month | 09 | Day |
Last modified on
| 2025 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065434
