UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056053 |
|---|---|
| Receipt number | R000064055 |
| Scientific Title | A pilot study of the usefulness of CXR-AID, a chest X-ray image lesion detection software, for different pathological conditions |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2024/11/06 10:21:17 |
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Basic information
Public title
A pilot study of the usefulness of CXR-AID, a chest X-ray image lesion detection software, for different pathological conditions
Acronym
A pilot study of the usefulness of CXR-AID, a chest X-ray image lesion detection software, for different pathological conditions
Scientific Title
A pilot study of the usefulness of CXR-AID, a chest X-ray image lesion detection software, for different pathological conditions
Scientific Title:Acronym
A pilot study of the usefulness of CXR-AID, a chest X-ray image lesion detection software, for different pathological conditions
Region
| Japan |
Condition
Condition
Abnormal shadow on chest X-ray
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A pilot study will be conducted to evaluate the usefulness of the chest X-ray image lesion detection software CXR-AID and to examine the effect of differences in prevalence and disease on its usefulness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection by CXR-AID
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
200 consecutive cases out of approximately 4,976 patients who underwent chest X-rays at our hospital's health checkup center between April 2022 and March 2023
30 consecutive cases out of 104 patients who underwent chest X-rays and further examinations at our hospital's health checkup center between April 2022 and March 2023
30 consecutive cases out of patients admitted to our hospital's respiratory medicine department with moderate COVID-19 I between April 2023 and March 2024
30 consecutive cases out of patients treated at our hospital's respiratory medicine department with lung cancer stage I and II between April 2023 and March 2024
10 consecutive cases out of patients treated at our hospital's respiratory medicine department with lung cancer complicated by interstitial pneumonia between April 2023 and March 2024
Key exclusion criteria
Staff medical examination at our hospital
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Kajiwara |
Organization
Matsuyama Red Cross Hospital
Division name
Department of Respiratory Medicine
Zip code
7908524
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
TEL
089-924-1111
respiratory24@outlook.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Kajiwara |
Organization
Matsuyama Red Cross Hospital
Division name
Department of Respiratory Medicine
Zip code
7908524
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
TEL
0899241111
Homepage URL
respiratory24@outlook.jp
Sponsor or person
Institute
Matsuyama Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsuyama Red Cross Hospital
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
Matsuyama Red Cross Hospital
Address
1 Bunkyo, Matsuyama, Ehime, Japan.
Tel
089-924-1111
respiratory24@outlook.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 | 11 | Month | 05 | Day |
Related information
URL releasing protocol
http://www.matsuyama.jrc.or.jp/
Publication of results
Published
Result
URL related to results and publications
http://www.matsuyama.jrc.or.jp/
Number of participants that the trial has enrolled
300
Results
The negative predictive value of CXR-AID in health checkups was extremely high, but the positive predictive value was low.
Results date posted
| 2024 | Year | 11 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We analyzed 198 cases who underwent chest X-rays at our hospital's health checkup center between April 2023 and March 2024.
Participant flow
none
Adverse events
none
Outcome measures
Patients who were judged to require further examination were defined as having "disease". Results: 20.7% (41/198) had a CXR-AID score of 15 or more, and a heat map was displayed. 3.5% (7/198) had disease, and the sensitivity at a cutoff value of 15 was 71.4%, the specificity was 81.1%, the positive predictive value was 12.1%, and the negative predictive value was 98.7%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In December 2022, our hospital introduced CXR-AID, a chest X-ray lesion detection software that uses AI technology, and has been using it for health checkups and medical treatment. We conducted a pilot study to investigate how CXR-AID can be used appropriately.
Methods: Data were collected using medical records and a retrospective analysis was performed.
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064055
