UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010023 |
|---|---|
| Receipt number | 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 10:15:09 |
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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
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
30mnaka@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011737
