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UMIN-CTR Clinical Trial |
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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 | 2022/07/08 |
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 |
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Condition | |||
Condition | Thoracic aortic aneurysm | ||
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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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 |
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Last modified on |
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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 |