UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037189
Receipt number R000042391
Scientific Title Evaluation of Computer-Assisted-Detection (CAD) software for Chest X-ray lung Nodule
Date of disclosure of the study information 2019/08/01
Last modified on 2022/06/29 10:45:23

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Basic information

Public title

Evaluation of Computer-Assisted-Detection (CAD) software for Chest X-ray lung Nodule

Acronym

Evaluation of Computer-Assisted-Detection (CAD) software for Chest X-ray lung Nodule

Scientific Title

Evaluation of Computer-Assisted-Detection (CAD) software for Chest X-ray lung Nodule

Scientific Title:Acronym

Evaluation of Computer-Assisted-Detection (CAD) software for Chest X-ray lung Nodule

Region

Japan


Condition

Condition

lung nodule

Classification by specialty

Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Validation of Computer-Assisted-Detection (CAD) software for Chest X-ray lung Nodule

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

ROC analysis, AUC

Key secondary outcomes

Sensitivity, Specificity, Ratio of false positive and Ratio of false negative.


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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patient who can be taken normal exams.
2) The resolution is bigger than 1750 x 1750 pixels.

Key exclusion criteria

1) No significant artifact or objects such as electrocardiograph.
2) Wrong/broken DICOM format.
3) The nodule size is less than 5mm or bigger than 30mm.
4) Diffused.
5) Other than circular shape.
6) Overlapped with organs.
7) Principal investigator determine as improper data.

Target sample size

320


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Yamamoto

Organization

Osaka City University, Graduate School of Medicine

Division name

Department of Diagnostic and Interventional Radiology

Zip code

545-8585

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka

TEL

06-6645-3831

Email

radiology@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Daiju
Middle name
Last name Ueda

Organization

Osaka City University, Graduate School of Medicine

Division name

Department of Diagnostic and Interventional Radiology

Zip code

545-8585

Address

1-4-3, Asahi-machi, Abeno-ku, Osaka

TEL

06-6645-3831

Homepage URL

http://ocu-radiology.jp/page-1392/

Email

radiology@med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University, Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

lpixel inc.

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

Osaka City University School of Medicine / University Hospital Management Office

Address

1-2-7-601, Asahi-machi, Abeno-ku, Osaka

Tel

06-6645-3456

Email

ethics@med.osaka-cu.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

2019 Year 08 Month 01 Day


Related information

URL releasing protocol

https://doi.org/10.1186/s12885-021-08847-9

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1186/s12885-021-08847-9

Number of participants that the trial has enrolled

312

Results

The overall increase in the ratios of sensitivity, specificity, accuracy, PPV, and NPV were 1.22 (1.14-1.30), 1.00 (1.00-1.01), 1.03 (1.02-1.04), 1.07 (1.0-1.11), and 1.02 (1.01-1.03) by using the CAD, respectively.

Results date posted

2022 Year 06 Month 29 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

In total, 312 chest radiographs were collected as a test dataset, including 59 malignant images (59 nodules of lung cancer) and 253 normal images.

Participant flow

The eligibility criteria for the radiographs were as follows: (1) Mass lesions larger than 30 mm in size were excluded. (2) Metastatic lung cancer that was not primary to the lung was excluded. (3) Lung cancers showing anything other than nodular lesions on radiograph were excluded. (4) Nodules in the chest radiographs were annotated with bounding box, referring to chest CT images by two board-certificated radiologists

Adverse events

Nothing

Outcome measures

Accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 06 Month 08 Day

Date of IRB

2019 Year 06 Month 27 Day

Anticipated trial start date

2019 Year 08 Month 01 Day

Last follow-up date

2019 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

multicenter, prospective observational study


Management information

Registered date

2019 Year 06 Month 27 Day

Last modified on

2022 Year 06 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042391


Research Plan
Registered date File name
2020/06/29 Plan.docx

Research case data specifications
Registered date File name
2020/06/29 The data specification.docx

Research case data
Registered date File name
2020/06/29 last_results.csv