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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037471
Receipt No. 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 2020/11/18

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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
Institute Iwate Medical University
Institute
Department

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 Preinitiation
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
2022 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
2020 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.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


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