UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047885 |
|---|---|
| Receipt number | R000054593 |
| Scientific Title | Deep learning based automatic detection of pathological uptake in [18F] DG PET/CT screening |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/05/28 09:46:15 |
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Basic information
Public title
Automatic detection of abnormal lesions in FDG-PET/CT screening using deep learning technology
Acronym
Automatic detection of abnormal lesions in FDG-PET/CT screening
Scientific Title
Deep learning based automatic detection of pathological uptake in [18F] DG PET/CT screening
Scientific Title:Acronym
Deep learning based automatic detection of pathological uptake in [18F] DG PET/CT screening
Region
| Japan |
Condition
Condition
Screening
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect abnormality in organs such as thyroid and gastrointestinal tract in FDG-PET/CT screening using deep learning.
Basic objectives2
Others
Basic objectives -Others
Accuracy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FDG Uptake in thyroid, stomach, duodenum, and large intestine
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects who agreed on a written document
2) Subjects who underwent studies such as thyroid ultrasound or gastrointestinal endoscopy to be training data
Key exclusion criteria
1) Subjects with artifacts on [18F] DG PET/CT
2) Subjects without complete [18F] DG PET/CT scanning
3) Subjects without any training data available such as ultrasound, blood test, fecal occult blood, or gastrointestinal endoscopy
4) Subjects who scored "E (diagnosed in other institutes)" with ultrasound or gastrointestinal endoscopy
5) Subjects who were considered as not eligible by investigators
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Nakamoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Diagnostic Radiology and Nuclear Medicine
Zip code
606-8507
Address
54 Kawahacho Shogoin Sakyoku Kyoto, Kyoto
TEL
075-751-3760
ynakamo1@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | W |
| Last name | Nobashi |
Organization
Kyoto University Hospital
Division name
Preemptive Medicine and Lifestyle Related Disease Research Center
Zip code
606-807
Address
54 Kawahacho Shogoin Sakyoku Kyoto, Kyoto
TEL
075-751-3760
Homepage URL
nobaco@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Midtown clinic, Kyoto Promed
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Konoecho Yoshida Sakyoku Kyoto, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
preinitiation
Management information
Registered date
| 2022 | Year | 05 | Month | 28 | Day |
Last modified on
| 2022 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054593
