UMIN-CTR Clinical Trial

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
Email	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
Email	nobaco@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054593