UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057573 |
|---|---|
| Receipt number | R000065762 |
| Scientific Title | A study of collimator differences in heart-mediastinum ratio in I-123 MIBG cardiac sympathetic nerve scintigraphy |
| Date of disclosure of the study information | 2025/04/10 |
| Last modified on | 2025/10/10 15:33:42 |
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Basic information
Public title
A study of collimator differences in heart-mediastinum ratio in I-123 MIBG cardiac sympathetic nerve scintigraphy
Acronym
A study of collimator differences in heart-mediastinum ratio in I-123 MIBG cardiac sympathetic nerve scintigraphy
Scientific Title
A study of collimator differences in heart-mediastinum ratio in I-123 MIBG cardiac sympathetic nerve scintigraphy
Scientific Title:Acronym
A study of collimator differences in heart-mediastinum ratio in I-123 MIBG cardiac sympathetic nerve scintigraphy
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of the collimator on the heart-mediastinum ratio in I-123 MIBG cardiac sympathetic nerve scintigraphy using a GE system, and to verify the validity of the previously reported collimator difference correction method using a point source for the GE system.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of collimators in heart-mediastinum ratio using point source correction method
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The examination time is extended by 10 minutes before and after the regular examination (total of 20 minutes), and the examination is performed using multiple collimators.
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 undergoing cardiac sympathetic scintigraphy for the evaluation of neurodegenerative diseases based on clinical need
Key exclusion criteria
none
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | KOHEI |
| Middle name | |
| Last name | MITSUI |
Organization
Kitasato University School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
252-0373
Address
1-15-1 Kitazato, Minami-ku, Sagamihara City, Kanagawa Prefecture
TEL
042-778-8111
mitsui.kohei@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | KOHEI |
| Middle name | |
| Last name | MITSUI |
Organization
Kitasato University School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
252-0373
Address
1-15-1 Kitazato, Minami-ku, Sagamihara City, Kanagawa Prefecture
TEL
042-778-7903
Homepage URL
mitsui.kohei@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Medicine and Hospital Ethics Committee
Address
1-15-1 Kitazato, Minami-ku, Sagamihara City, Kanagawa Prefecture
Tel
042-778-8111
none
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 | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 04 | Month | 10 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065762
