UMIN-CTR Clinical Trial

Public title

Japanese Multi-Center Study for Utility of 3D Computer-Aided Detection System at Lung Cancer Screening with Low-dose CT Protocol

Acronym

Japanese Multi-Center Trial of 3D CAD System and Low-Dose CT Protocol for Lung cancer Screening

Scientific Title

Japanese Multi-Center Study for Utility of 3D Computer-Aided Detection System at Lung Cancer Screening with Low-dose CT Protocol

Scientific Title:Acronym

Japanese Multi-Center Trial of 3D CAD System and Low-Dose CT Protocol for Lung cancer Screening

Region

Japan

Condition

Pulmonary nodule

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Comparison of nodule detection capability among CAD system alone and CAD system with concurrent and second reading method by physicians.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

Results of compared nodule detection capability among CAD system alone and CAD system with concurrent and second reading method by physicians.

Key secondary outcomes

1. Comparison of quantitative image quality at various dose CTs among FBP, AIDR 3D and FIRST
2. Comparison of qualitative image quality at various dose CTs among FBP, AIDR 3D and FIRST
3. Comparison for nodule detection capability of CAD system among standard-, reduced- and ultra-low-dose CTs
4. Comparison for nodule detection capability at standard-, reduced- and ultra-low-dose CTs among CAD system alone and CAD system with concurrent and second reading methods by physicians

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Comparison of nodule detection capability among CAD alone and CAD with concurrent and second reading methods with physicians

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

Age-lower limit

40

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Equal to or more than 40-years old
2. Written informed consent is obtained.
3. Patients with radiological, microbacterial, histological and laboratorial as well as more than two-years follow-up CT examinations are performed.

Key exclusion criteria

1. Already included subject
2. Pregnant woman or female with possibility for pregnancy
3. Patients who undergo standard-dose CT examination and don't allow any further radiation exposure.
4. Patient who is considered as non inclusive by researchers

Target sample size

600

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiharu Ohno

Organization

Kobe University Hospital

Division name

Department of Radiology

Zip code

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan

TEL

078-382-6104

Email

yosirad@kobe-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shinichiro Seki

Organization

Kobe University Hospital

Division name

Department of Radiology

Zip code

Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan

TEL

+81-78-382-6104

Homepage URL

Email

klfsiena@yahoo.co.jp

Institute

Department of Radiology, Kobe University Hospital

Institute

Department

Personal name

Organization

Canon Medical Systems Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大原綜合病院（福島県），神奈川県立循環器呼吸器病センター（神奈川県），産業医科大学病院（福岡），静岡県立がんセンター（静岡）

Date of disclosure of the study information

2018

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2017

Year

12

Month

05

Day

Date of IRB

2019

Year

02

Month

25

Day

Anticipated trial start date

2019

Year

02

Month

25

Day

Last follow-up date

2019

Year

02

Month

25

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Due to the principle investigators' moving out from Kobe University, this research project was terminated on February 25, 2019.

Registered date

2017

Year

12

Month

15

Day

Last modified on

2019

Year

05

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034727