UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019673
Receipt number R000022732
Scientific Title Image quality of new reconstruction algorithm for low-dose lung CT images using 64-row MDCT.
Date of disclosure of the study information 2015/11/09
Last modified on 2020/01/18 05:55:43

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Basic information

Public title

Image quality of new reconstruction algorithm for low-dose lung CT images using 64-row MDCT.

Acronym

Image quality of new reconstruction algorithm for low-dose CT of the lung.

Scientific Title

Image quality of new reconstruction algorithm for low-dose lung CT images using 64-row MDCT.

Scientific Title:Acronym

Image quality of new reconstruction algorithm for low-dose CT of the lung.

Region

Japan


Condition

Condition

Pulmonary nodule and interstitial pneumonia

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the feasibility of Model-Based Iterative Reconstruction for low dose lung CT by comparing with filtered back projection and Adaptive Statistical Iterative Reconstruction.

Basic objectives2

Others

Basic objectives -Others

To assess the feasibility of new reconstruction algorithm (Model-Based Iterative Reconstruction)

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Give subjective score according to the 3-5 grade evaluation system for each reconstruction image.

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who intend to have chest CT for evaluation of pulmonary nodule or interstitial pneumonia.

Key exclusion criteria

Unable to obtain informed consent; pregnancy; Body Mass Index is more than 35 kg/m2.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Yanagawa

Organization

Osaka University Graduate School of Medicine

Division name

Diagnostic and Interventional Radiology

Zip code

565-0871

Address

2-2 Yamadaoka,Suita,Osaka

TEL

06-6879-3434

Email

m-yanagawa@radiol.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Akinori
Middle name
Last name Hata

Organization

Osaka University Graduate School of Medicine

Division name

Diagnostic and Interventional Radiology

Zip code

565-0871

Address

2-2 Yamadaoka,Suita,Osaka

TEL

06-6879-3434

Homepage URL


Email

a-hata@radiol.med.osaka-u.ac.jp


Sponsor or person

Institute

Diagnostic and Interventional Radiology, Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

GE Healthcare Japan

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

Department of Medical Innovation Osaka University Hospital

Address

Innovation Center, 2-2 Yamadaoka, Suita, Osaka

Tel

06-6210-8289

Email

rinri@hp-crc.med.osaka-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

2015 Year 11 Month 09 Day


Related information

URL releasing protocol

http://radiol-osaka-u.com/publication/ethics/%e8%87%a8%e5%ba%8a%e7%97%87%e4%be%8b%e3%81%ab%e3%81%8a%

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6708979/#!po=43.7500

Number of participants that the trial has enrolled

100

Results

This study was registered as discontinued because it had no intervention and it was difficult to report the appropriate format.
Using this study data, the following papers were published.

Hata A, Yanagawa M, Honda O, et al. Medicine (Baltimore). 2019 May;98(22):e15936.
Hata A, Yanagawa M, Kikuchi N, et al. J Comput Assist Tomogr. 2018 Sep/Oct;42(5):760-766.

Results date posted

2020 Year 01 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients were identified from referral to the department for a non-contrast chest CT specifically for follow-up of previously detected ILD findings.

Participant flow

All patients provided written, informed consent and underwent ultra-low-dose CT in addition to standard-dose CT for clinical purposes.

Adverse events

N/A

Outcome measures

Image findings including noise, streak artifact, bronchiectasis, reticulation, ground-glass opacity, and honeycomb. Densitometry for interstitial lung disease.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2015 Year 11 Month 09 Day

Date of IRB

2015 Year 08 Month 13 Day

Anticipated trial start date

2016 Year 01 Month 04 Day

Last follow-up date

2018 Year 11 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We recruit patients who were pointed out to have pulmonary nodule or interstitial pneumonia in previous CT and intend to have chest CT for follow up.
Recruitment period is from Nov. 9, 2015 to Dec. 31, 2020.


Management information

Registered date

2015 Year 11 Month 06 Day

Last modified on

2020 Year 01 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022732


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name