UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of lung function pre and post resection using Xenon- and contrast-enhanced dual energy CT(Xe-Ce-De-CT)
Title of the study (Brief title)	Evaluation of lung function pre and post resection using Xenon- and contrast-enhanced dual energy CT(Xe-Ce-De-CT)
Region	Japan

Condition
Condition	conditions which require lung resection
Classification by specialty	Chest surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the changes in lung function, particularly the changes in ventialtion/perfusion ratios pre vs post lung resection
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	vetilation/perfusion image
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	Xenon- and contrast-enhanced dual energy CT, and ventilation perfusion scan
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.Older than 20 years 2.Planned lung resection segmentectomy or more
Key exclusion criteria	1. Unable to undergo contrast enhancement 2.Unable to undergo CT scans
Target sample size	50

Research contact person
Name of lead principal investigator	Mitsuo Nakayama
Organization	Saitama Medical Center
Division name	General thoracic surgery
Address	1981 Kamoda Kawagoe City, Saitama Prefecture
TEL	042-228-3459
Email	30mnaka@saitama-med.ac.jp

Public contact
Name of contact person	Mitsuo Nakayama
Organization	Saitama Medical Center
Division name	General thoracic surgery
Address	1981 Kamoda Kawagoe City, Saitama Prefecture
TEL	042-228-3459
Homepage URL
Email	30mnaka@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center
Institute
Department

Funding Source
Organization	Saitama Medical Center, Division of general thoracic surgery
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2013 Year 02 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 13 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2017 Year 10 Month 31 Day
Date of closure to data entry	2017 Year 10 Month 31 Day
Date trial data considered complete	2017 Year 10 Month 31 Day
Date analysis concluded	2018 Year 01 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://cardiothoracicsurgery.biomedcentral.com/articles/10.1186/s13019-018-0737-2
Results	BACKGROUND: While many studies have evaluated the change in lung volume before and after lung resection and correlated this with pulmonary function test results, there is very little evidence on the changes in ventilation perfusion ratio (V/Q) before versus after lung resection. In the present pilot study, we evaluated if V/Q mapping can be constructed using dual energy CT images. METHODS: Thirty-one lung cancer patients planned for pulmonary resection were included in this study. To evaluate ventilation, Xenon-enhanced CT was performed. This was immediately followed by perfusion CT. The two images were registered manually as well as using dedicated softwares, and division between ventilation pixels and perfusion pixels were done to produce the V/Q map. Also, in order to characterize the distribution of the V/Q, the following numerical indices were calculated; mean, median, mode, standard deviation (SD), coefficient of variation (CV), skewness, kurtosis, and fractal dimension (FD). Pulmonary function tests and blood gas parameters were measured using standard institutional procedures. RESULTS: In the whole group, VC, %VC, and FEV1 decreased significantly after resection. FEV1.0% was increased significantly after resection. No significant changes were seen in PaO2, PaCO2, and DLCO/VA before and after resection. The mean, median, mode, SD, skewness, kurtosis and FD of the V/Q did not change significantly before and after resection. A marginal but significant decrease in CV was seen before versus after resection. CONCLUSIONS: Overall, it was considered that the V/Q maps could be adequately generated in this study. With further accumulation of data, V/Q map generated by dual energy CT may become one of the potentially useful tools for functional lung imaging.
Other related information

Management information
Registered date	2013 Year 02 Month 13 Day
Last modified on	2018 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011737