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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046568
Receipt No. 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 2022/01/06

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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
Email 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
Email a.suzuki.eh@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Email 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
2022 Year 01 Month 06 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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