UMIN-CTR Clinical Trial

Basic information
Public title	Study on the efficacy of upright computed-tomography scan for thoracic surgical diseases
Acronym	Study on the efficacy of upright computed-tomography scan for thoracic surgical diseases
Scientific Title	Study on the efficacy of upright computed-tomography scan for thoracic surgical diseases
Scientific Title:Acronym	Study on the efficacy of upright computed-tomography scan for thoracic surgical diseases
Region	Japan

Condition
Condition	Thoracic surgical diseases
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare morphological features in patients with thoracic surgical diseases among standing and supine positions using upright and conventional CT. To explore the relationship between morphological parameters on CT images and clinical data.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Morphological parameters on CT images Concrete primary outcomes are not determined, because this study is an exploratory study.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Upright CT scan in a standing position
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Subjects who are referred for CT examination for the assessment of thoracic surgical diseases 2. Age equal to or more than 20 years 3. Subjects who provide written informed consent
Key exclusion criteria	1. Known or possible pregnancy 2. Subjects who are not able to undergo CT examination in a standing position 3. Subjects who do not provide written informed consent
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Jinzaki
Organization	Keio University School of Medicine
Division name	Department of Radiology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo.
TEL	03-5363-3836
Email	jinzaki@rad.keio.ac.jp

Public contact
Name of contact person	1st name Keisuke Middle name Last name Asakura
Organization	Keio University School of Medicine
Division name	Division of Thoracic Surgery, Department of Surgery
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo.
TEL	03-5363-3806
Homepage URL
Email	asakura@z6.keio.jp

Sponsor
Institute	Department of Radiology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University School of Medicine Ethics committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo.
Tel	03-5363-3503
Email	med-rinri-jimu@adst.keio.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 04 Month 08 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 04 Month 02 Day
Date of IRB	2019 Year 04 Month 08 Day
Anticipated trial start date	2019 Year 04 Month 22 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 07 Day
Last modified on	2022 Year 04 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041519