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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010023
Receipt No. R000011737
Scientific Title Evaluation of lung function pre and post resection using Xenon- and contrast-enhanced dual energy CT(Xe-Ce-De-CT)
Date of disclosure of the study information 2013/02/13
Last modified on 2018/09/13

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Basic information
Public title Evaluation of lung function pre and post resection using Xenon- and contrast-enhanced dual energy CT(Xe-Ce-De-CT)
Acronym Evaluation of lung function pre and post resection using Xenon- and contrast-enhanced dual energy CT(Xe-Ce-De-CT)
Scientific Title Evaluation of lung function pre and post resection using Xenon- and contrast-enhanced dual energy CT(Xe-Ce-De-CT)
Scientific Title:Acronym 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
1st name
Middle name
Last name Mitsuo Nakayama
Organization Saitama Medical Center
Division name General thoracic surgery
Zip code
Address 1981 Kamoda Kawagoe City, Saitama Prefecture
TEL 042-228-3459
Email 30mnaka@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuo Nakayama
Organization Saitama Medical Center
Division name General thoracic surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://cardiothoracicsurgery.biomedcentral.com/articles/10.1186/s13019-018-0737-2
Number of participants that the trial has enrolled
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.
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 Completed
Date of protocol fixation
2013 Year 02 Month 13 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000011737

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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