UMIN-CTR Clinical Trial

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 07 Month 08 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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