UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061894 |
|---|---|
| Receipt number | R000070780 |
| Scientific Title | Optimization of 99mTc-HMDP Myocardial Uptake Assessment Based on Quantitative SPECT Simulation: Proposal of a Correction Model for Heart-Bone Reciprocal Phenomenon and Background Variations |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/12 18:58:29 |
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Basic information
Public title
Development of a New Evaluation Method to Remove Image Noise and Detect Heart Disease Accurately
Acronym
NEMO-Heart (New Evaluation Method Optimization for Heart)
Scientific Title
Optimization of 99mTc-HMDP Myocardial Uptake Assessment Based on Quantitative SPECT Simulation: Proposal of a Correction Model for Heart-Bone Reciprocal Phenomenon and Background Variations
Scientific Title:Acronym
HMDP-MUA (99mTc-HMDP Myocardial Uptake Assessment)
Region
| Japan |
Condition
Condition
cardiac amyloidosis
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the impact of background activity in the lungs and blood pool on the heart-to-contralateral lung (H/CL) ratio in 99mTc-HMDP SPECT, utilizing quantitative Monte Carlo simulations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The heart-to-contralateral lung (H/CL) ratio, the heart-to-whole-body (H/WB) ratio, and the standardized uptake value (SUV) of the background regions (lungs and blood pool)
Key secondary outcomes
Base
Study type
Observational
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
| 18 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male
Key inclusion criteria
Adult patients who underwent nuclear medicine examinations using 99mTc-HMDP.
Key exclusion criteria
Patients with significant image artifacts (e.g., severe patient motion) that hinder analysis.
Patients with suspected non-specific uptake of bone-seeking tracers due to a history of acute myocardial infarction within the previous 6 months, severe active myocarditis, chest trauma, or prior chest radiation therapy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Nosaka |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Radiological Sciences
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
TEL
029-888-4000
nosakahi@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Nosaka |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Radiological Sciences
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
TEL
029-888-4000
Homepage URL
nosakahi@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University of Health Sciences
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
Tel
029-888-4000
nosakahi@ipu.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
| 2026 | Year | 06 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 02 | 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
Study Design
Single-center retrospective observational study
Subject Recruitment Method and Period
All consecutive adult patients who underwent a nuclear medicine examination using 99mTc-HMDP at this facility between April 1, 2024, and March 31, 2027, and who met the inclusion criteria.
Main Measurement and Evaluation Items
The following items will be measured and evaluated using existing image data.
Accumulation count values in various regions of interest (ROIs) will be measured, and quantitative indices such as the H/CL ratio and H/WB ratio will be calculated.
The impact of differences in image reconstruction parameters (e.g., FBP, OSEM) and background ROI settings on the stability of the above indices will be compared and examined.
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Management information
Registered date
| 2026 | Year | 06 | Month | 12 | Day |
Last modified on
| 2026 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070780
