UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016845 |
|---|---|
| Receipt number | R000019558 |
| 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 |
| Date of disclosure of the study information | 2015/03/19 |
| Last modified on | 2021/03/23 13:13:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
k16@saitama-med.ac.jp
Sponsor or person
Institute
Keiichiro Nishimura
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019558
