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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054593


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name