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

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 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


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

Value
https://center6.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