UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054523 |
|---|---|
| Receipt number | R000062297 |
| Scientific Title | Investigation of the molecular pathogenesis of cardiac amyloidosis using 18F-flutemetamol and 11C-PiB PET/CT and 99mTc-HMDP scintigraphy. |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2025/12/08 12:22:24 |
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Basic information
Public title
Investigation of the molecular pathogenesis of cardiac amyloidosis using 18F-flutemetamol and 11C-PiB PET/CT and 99mTc-HMDP scintigraphy.
Acronym
FMM, PiB, and HMDP accumulation in cardiac amyloidosis
Scientific Title
Investigation of the molecular pathogenesis of cardiac amyloidosis using 18F-flutemetamol and 11C-PiB PET/CT and 99mTc-HMDP scintigraphy.
Scientific Title:Acronym
FMM, PiB, and HMDP accumulation in cardiac amyloidosis
Region
| Japan |
Condition
Condition
cardiac amyloidosis
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients diagnosed or suspected of having cardiac amyloidosis will undergo 18F-flutemetamol and 11C-PiB PET/CT examinations to image amyloid and elucidate the pathological mechanism of the disease based on the accumulation patterns of these tracers.
Basic objectives2
Others
Basic objectives -Others
We will compare these patterns with the accumulation of 99mTc-HMDP, a nuclear medicine test commonly used in clinical practice, to differentiate between amyloid deposition and calcified deposition, thereby further elucidating the disease cascade.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
18F-flutemetamol PET/CT accumulation pattern or absence of accumulation in cardiac amyloidosis
Key secondary outcomes
Differences between 18F-flutemetamol PET/CT and 11C-PiB PET/CT and 99mTc-HMDP scintigraphy in cardiac amyloidosis according to degree of accumulation and clinical severity
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
One PET scan for 18F-flutemetamol and 11C-PiB, and one 99mTc-HMDP scintigraphy will be performed on eligible patients.
The order of each imaging examination is unequal, and although no interval between examinations is specified, all examinations should be performed within 3 months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with or suspected of having cardiac amyloidosis
Key exclusion criteria
Patients who are or may be pregnant
Patients with an immediate and obvious life-threatening condition
Other patients deemed inappropriate by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Norikane |
| Middle name | |
| Last name | Takashi |
Organization
Kagawa University
Division name
Department of Radiology
Zip code
761-0793
Address
1750-1, Ikenobe, Miki-cho, Kita-gun
TEL
087-898-5111
radiol-m@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Norikane |
| Middle name | |
| Last name | Takashi |
Organization
Kabawa University
Division name
Department of Radiology
Zip code
761-0793
Address
1750-1, Ikenobe, Miki-cho, Kita-gun
TEL
087-898-5111
Homepage URL
radiol-m@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Takashi Norikane
Funding Source
Organization
Nihon Medi-Physics Co.,Ltd.
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
Kagawa University
Address
1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa
Tel
0878985111
kenkyushien@kagawa-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
| 2024 | Year | 05 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 31 | Day |
Last modified on
| 2025 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062297
