UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037471
Receipt number R000042681
Scientific Title Feasibility of deep learning reconstruction in abdominal CT: Optimization and validation
Date of disclosure of the study information 2020/04/02
Last modified on 2022/07/26 09:03:08

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Basic information

Public title

Feasibility of deep learning reconstruction in abdominal CT: Optimization and validation

Acronym

Feasibility of deep learning reconstruction in abdominal CT: Optimization and validation

Scientific Title

Feasibility of deep learning reconstruction in abdominal CT: Optimization and validation

Scientific Title:Acronym

Feasibility of deep learning reconstruction in abdominal CT: Optimization and validation

Region

Japan


Condition

Condition

Patients with abnormal laboratory test results or upper abdominal symptoms that raised suspicions of abdominal malignancy underwent dynamic CT.

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether an iterative reconstruction algorithm and a deep learning reconstruction algorithm improves the image quality in abdominal CT

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Objective assessment of image quality

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

18 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Our inclusion criteria were history or suspicion of abdominal tumor, such as hepatocellular carcinoma, cholangiocellular carcinoma, hemangioma, or metastatic liver tumor.

Key exclusion criteria

Our exclusion criteria were as follows:emergency case, history of an adverse reaction to iodinated contrast media, proved or suspected pregnancy, and no history of hepatic surgery, TAE, RFA, or renal surgery.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Akio
Middle name
Last name Tamura

Organization

Iwate Medical University

Division name

Depertment of Radiology

Zip code

020-8505

Address

19-1, Uchimaru, Morioka

TEL

0196515111

Email

a.akahane@gmail.com


Public contact

Name of contact person

1st name Akio
Middle name
Last name Tamura

Organization

Iwate Medical University

Division name

Depertment of Radiology

Zip code

020-8505

Address

19-1, Uchimaru, Morioka

TEL

0196515111

Homepage URL


Email

a.akahane@gmail.com


Sponsor or person

Institute

Iwate Medical University

Institute

Department

Personal name



Funding Source

Organization

Iwate Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Iwate Medical University

Address

19-1, Uchimaru, Morioka

Tel

+81196515111

Email

a.akahane@gmail.com


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

2020 Year 04 Month 02 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

Enrolling by invitation

Date of protocol fixation

2019 Year 07 Month 24 Day

Date of IRB

2020 Year 10 Month 05 Day

Anticipated trial start date

2020 Year 04 Month 02 Day

Last follow-up date

2023 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2019 Year 07 Month 24 Day

Last modified on

2022 Year 07 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042681


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name