UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046568 |
|---|---|
| Receipt number | R000052794 |
| Scientific Title | Assessment of Clinical Performance of an AI Program for Measuring Thoracic Aortic Diameter |
| Date of disclosure of the study information | 2022/01/11 |
| Last modified on | 2023/01/07 12:57:28 |
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Basic information
Public title
Assessment of Clinical Performance of an AI Program for Measuring Thoracic Aortic Diameter
Acronym
Assessment of Clinical Performance of an AI Program for Measuring Thoracic Aortic Diameter
Scientific Title
Assessment of Clinical Performance of an AI Program for Measuring Thoracic Aortic Diameter
Scientific Title:Acronym
Assessment of Clinical Performance of an AI Program for Measuring Thoracic Aortic Diameter
Region
| Japan |
Condition
Condition
Thoracic aortic aneurysm
Classification by specialty
| Radiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical feasibility of AI-assisted measurement of the aortic diameter.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of aorta diameters on non-contrast CT images measured by a medical doctor with the assistance of the prototype AI software and those on contrast enhanced CT images assessed by medical doctors (ground truth).
Key secondary outcomes
1. Comparison of aortic diameter measurement solely by a medical doctor or by the AI software using non-contrast CT and ground truth.
2. Comparison of aortic diameter measurements solely by the AI software using contrast enhanced CT and ground truth.
3. Comparison of aortic diameter measurement by maximal short diameter method and ground truth.
4. Influence of the AI software on interobserver variance.
5. Influence of the AI software on the reading time.
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
| 22 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled for CT scan to examine aortic disease, especially thoracic aortic aneurysm or to follow-up thoracic aortic aneurysm.
Key exclusion criteria
1) Suboptimal image quality of the thoracic aorta limiting evaluation of the aortic diameter.
2) Under 22 years of age at the time of obtaining consent.
3) With allergy to iodine contrast media.
4) With active asthma.
5) With Grade 4 or higher renal dysfunction (eGFR less than 30 ml/min/1.73m2).
6) Others who are judged by the principal investigator to be unsuitable as subjects.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Tomizawa |
Organization
Juntendo University Hospital
Division name
Department of Radiology
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
n-tomizawa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Akiyoshi |
| Middle name | |
| Last name | Suzuki |
Organization
Juntendo University Hospital
Division name
Department of Radiology
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
a.suzuki.eh@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Juntendo University School of Medicine
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1584
hongo-rinri@juntendo.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
Juntendo University Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 11 | 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
| 2021 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To observe CT images performed for examination of aortic disease such as aortic aneurysm or for follow-up of aortic aneurysm.
Management information
Registered date
| 2022 | Year | 01 | Month | 06 | Day |
Last modified on
| 2023 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052794
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
