UMIN-CTR Clinical Trial

Basic information
Public title	Comparative study of lung ventilation CT images under the condition of breathing Xenon gas with lung ventilation 4D-CT images to evaluate functional treatment planning for patient with non-small cell lung cancer
Acronym	Comparative study of lung ventilation CT of Xenon gas with 4D-CT for radiotherapy planning
Scientific Title	Comparative study of lung ventilation CT images under the condition of breathing Xenon gas with lung ventilation 4D-CT images to evaluate functional treatment planning for patient with non-small cell lung cancer
Scientific Title:Acronym	Comparative study of lung ventilation CT of Xenon gas with 4D-CT for radiotherapy planning
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In chemoradiotherapy (or radiotherapy) for the unresectable local progress non-small cell lung cancer, it is extremely important to suppress the onset of the radiation pneumonitis after the treatment.In a prediction of the radiation pneumonitis V20 (ratio of lung irradiated more than 20 Gy) and MLD (mean lung dose;) It is said that an evaluation of mean pulmonary dosage) is important.However, current V20 is calculated based on anatomical embryonate, and the lung function is not added. Therefore, as for us, radiation treatment planning using the lung function image usually examines the effect that the existing lung gives as compared with the treatment plan using the CT image.Generally, we weigh V20, the MLD which we perform the CT (we apply cerebral blood stream volume xenon CT that is insurance adaptation to the ventilation measurement of the lung) image which we make a lung function image made except the low-attenuation foci in a performed CT image and cold xenon inhaled and imaged, radiation treatment planning for each and calculated.In addition, we weigh it against V20, the MLD by false lung ventilation image obtained from anatomical CT image and the 4D-CT image.We arrive at Functional DVH (dose volume histogram) (functional dosage volume histogram) which is a new radiotherapy general idea after having examined a utility of the technique to evaluate a local lung function pictorially, and it is a purpose to demand a radiation pneumonitis predictor after the radiotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Xenon-CT radiotherapy treatment planning;V20,MLD;mean lung dose 4D-CT radiotherapy treatment planning ;V20,MLD;mean lung dose
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	Treatment
Type of intervention	Medicine
Interventions/Control_1	radiotherapy treatment plan using Xenon-CT
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	The patient who undergo radiation therapy for local progress non-small-cell lung cancer
Key exclusion criteria	Patient during the pregnancy, the nursing
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Keiichiro Middle name Last name Nishimura
Organization	Saitama Medical Center
Division name	radiation oncology
Zip code	3508550
Address	1981, Kamoda, Kawagoe-shi, Saitama, Japan
TEL	049-228-3511
Email	k16@saitama-med.ac.jp

Public contact
Name of contact person	1st name Keiichiro Middle name Last name Nishimura
Organization	Saitama Medical Center
Division name	radiation oncology
Zip code	3508550
Address	1981, Kamoda, Kawagoe-shi, Saitama, Japan
TEL	049-228-3511
Homepage URL
Email	k16@saitama-med.ac.jp

Sponsor
Institute	Keiichiro Nishimura
Institute
Department

Funding Source
Organization	Saitama Medical Center, radiation oncology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Saitama Medical Center
Address	1981, Kamoda, Kawagoe-shi, Saitama, Japan
Tel	0492283511
Email	k16@saitama-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

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	12
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	Completed
Date of protocol fixation	2015 Year 03 Month 19 Day
Date of IRB	2015 Year 08 Month 27 Day
Anticipated trial start date	2015 Year 03 Month 19 Day
Last follow-up date	2018 Year 03 Month 30 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 03 Month 19 Day
Last modified on	2021 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019558