UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058122 |
|---|---|
| Receipt number | R000066437 |
| Scientific Title | Prediction of Atherosclerotic Calcified Plaque Progression Using 18F-NaF PET/CT: A Systematic Review and Meta-analysis |
| Date of disclosure of the study information | 2025/06/10 |
| Last modified on | 2025/06/11 19:29:01 |
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Basic information
Public title
Using 18F-NaF PET/CT to Predict the Progression of Artery Calcification: A Plain-Language Summary of Research
Acronym
18F-NaF PET/CT for Predicting Calcified Plaque Progression
Scientific Title
Prediction of Atherosclerotic Calcified Plaque Progression Using 18F-NaF PET/CT: A Systematic Review and Meta-analysis
Scientific Title:Acronym
18F-NaF PET/CT for Predicting Calcified Plaque Progression
Region
| Japan |
Condition
Condition
Atherosclerosis
Classification by specialty
| Cardiology | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to systematically evaluate whether there is a significant correlation between 18F-NaF uptake intensity in calcified atherosclerotic plaques, as measured by the tissue-to-background ratio (TBR) on 18F-NaF PET/CT, and the progression of calcification quantified by changes in Agatston score units. Through a meta-analysis of relevant studies, we aim to clarify the strength and consistency of this relationship, which may help establish 18F-NaF uptake as a predictive imaging biomarker for arterial calcification progression.
Basic objectives2
Others
Basic objectives -Others
To evaluate the correlation between 18F-NaF uptake intensity and the progression of calcification scores
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Meta-analysis of the correlation between 18F-NaF uptake intensity (TBR: tissue-to-background ratio) and the increase in Agatston score units
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Not applicable (meta-analysis)
Key exclusion criteria
Not applicable (meta-analysis)
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Ishiwata |
Organization
Yokohama City University Hospital
Division name
Department of Nuclear Medicine
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872800
ishi_y@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Ishiwata |
Organization
Yokohama City University Hospital
Division name
Department of Nuclear Medicine
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872800
Homepage URL
ishi_y@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding
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
Not applicable (meta-analysis)
Address
Not applicable (meta-analysis)
Tel
Not applicable (meta-analysis)
Not applicable (meta-analysis)
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 | 06 | 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
| 2025 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a systematic review and meta-analysis based on previously published data. No new patient recruitment or intervention is involved. No funding was received for this work. Ethical approval was deemed not applicable.
Management information
Registered date
| 2025 | Year | 06 | Month | 09 | Day |
Last modified on
| 2025 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066437
