UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055286 |
|---|---|
| Receipt number | R000063136 |
| Scientific Title | Application of Salivary Gland Scintigraphy and Thyroid Technescintigraphy in the Detection of Subclinical Aspiration ~Investigation in normal cases with the assumption that a validation study will be performed~. |
| Date of disclosure of the study information | 2024/08/24 |
| Last modified on | 2024/08/20 14:24:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Application of Salivary Gland Scintigraphy and Thyroid Technescintigraphy in the Detection of Subclinical Aspiration
~Investigation in normal cases with the assumption that a validation study will be performed~.
Acronym
Aspiration scintigraphy
Scientific Title
Application of Salivary Gland Scintigraphy and Thyroid Technescintigraphy in the Detection of Subclinical Aspiration
~Investigation in normal cases with the assumption that a validation study will be performed~.
Scientific Title:Acronym
Subclinical aspiration detection scintigraphy
Region
| Japan |
Condition
Condition
Normal adult without history of aspiration
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm that normal adults without aspiration do not develop abnormal accumulation when chest imaging is performed after salivary gland scintigraphy (confirmation in normal cases)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of normal adults without abnormal accumulation in chest after salivary gland scintigraphy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons who will have a salivary gland scintigraphy performed under national health insurance
People with no history of aspiration pneumonia
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Hirasawa |
Organization
Gunma University Hospital
Division name
Department of Radiology
Zip code
371-8511
Address
3-39-15 Showa-machi Maebashi Gunma
TEL
027-220-8612
h.hirasawa@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Hirasawa |
Organization
Gunma University Hospital
Division name
Department of Radiology
Zip code
371-8511
Address
3-39-15 Showa-machi Maebashi Gunma
TEL
027-220-8612
Homepage URL
h.hirasawa@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Hiromi Hirasawa
Funding Source
Organization
Japan Society for the promotion of science (Grants-in-Aid for Scientific Research)
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
Gunma University Hospital
Address
3-39-15 Showa-machi Maebashi Gunma
Tel
027-220-8740
hitsujiharuka@yahoo.co.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 | 08 | Month | 24 | 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 | 15 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Inclusion criteria: Patients who have no history of aspiration pneumonia and for whom a salivary gland scintigraphy will be taken.
Perform chest imaging after the salivary gland scintigraphy is completed and also the next day.
It is presumed that there will be no accumulation in the lungs in patients who have not aspirated.
At the same time, a simple aspiration test called the cough test will be performed and compared.
Management information
Registered date
| 2024 | Year | 08 | Month | 20 | Day |
Last modified on
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063136
