UMIN-CTR Clinical Trial

Basic information
Public title	The usefulness of minimally invasive dynamic inspection technology (chest radiography) to prediction of perioperative pulmonary function after resection for lung cancer
Acronym	The usefulness of minimally invasive dynamic inspection technology (chest radiography) to prediction of perioperative pulmonary function after resection for lung cancer
Scientific Title	The usefulness of minimally invasive dynamic inspection technology (chest radiography) to prediction of perioperative pulmonary function after resection for lung cancer
Scientific Title:Acronym	The usefulness of minimally invasive dynamic inspection technology (chest radiography) to prediction of perioperative pulmonary function after resection for lung cancer
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Development of software capable of evaluating dynamically functioning of respiration and circulation using flat-panel detector (FDP)-based functional X-ray imaging, and evaluation of more physiological pulmonary function after resection for lung cancer using this software.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Pre- and postoperative 1) Dynamic X-ray imaging 2) Ventilation/perfusion mapping images 3) Diaphragm excursion 4) Difference of chest expansion 5) Predicted postoperative pulmonary function
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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Examination of flat-panel detector (FDP)-based functional X-ray imaging in the perioperative period
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) Patient who has confirmed diagnosis of primary lung cancer or is strongly suspected, has surgical indication for radical resection, scheduled to be operated or performed. 2) Forced breathing, deep breathing, breath holding are possible in standing or supine position. 3) Informed consent for clinical trial (document).
Key exclusion criteria	1) women in pregnancy 2) Patients judged for inappropriation by attending physician or lead principal investigator
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Hanaoka
Organization	Shiga University of Medical Science
Division name	General Thoracic Surgery
Zip code	5202192
Address	Seta-Tsukinowa, Otsu, Shiga, Japan
TEL	+81-077-548-2244
Email	hanaoka@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Hanaoka
Organization	Shiga University of Medical Science
Division name	General Thoracic Surgery
Zip code	5202192
Address	Seta-Tsukinowa, Otsu, Shiga, Japan
TEL	+81-077-548-2244
Homepage URL
Email	hanaoka@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Konica Minolta
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	SUMS research ethics committee
Address	Seta-Tsukinowa, Otsu, Shiga, Japan
Tel	0775483576
Email	hqrec@belle.shiga-med.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	滋賀医科大学附属病院（滋賀県）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	100
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	Main results already published
Date of protocol fixation	2017 Year 10 Month 04 Day
Date of IRB	2017 Year 09 Month 26 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 12 Month 31 Day
Date analysis concluded	2023 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 10 Month 25 Day
Last modified on	2022 Year 10 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033957