UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014825 |
|---|---|
| Receipt number | R000017206 |
| Scientific Title | Evaluation of the feasibility of dynamic tumor-tracking irradiation without implanted fiducial marker based on 4D-CBCT. |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2023/09/30 14:39:29 |
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Basic information
Public title
Evaluation of the feasibility of dynamic tumor-tracking irradiation without implanted fiducial marker based on 4D-CBCT.
Acronym
Evaluation of the feasibility of dynamic tumor-tracking irradiation based on 4D-CBCT.
Scientific Title
Evaluation of the feasibility of dynamic tumor-tracking irradiation without implanted fiducial marker based on 4D-CBCT.
Scientific Title:Acronym
Evaluation of the feasibility of dynamic tumor-tracking irradiation based on 4D-CBCT.
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of the dynamic tumor-tracking irradiation without implanted fiducial markers by acquiring and analyzing 4-dimensional cone-beam CT (4D CB-CT) images.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility of the dynamic tumor-tracking irradiation based on 4D-CBCT without fiducial marker.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients with early stage lung cancer (T1a-T2aN0M0) or 1-3 metastatic lung cancer who will be treated with dynamic tumor-tracking stereotactic body radiation therapy.
Key exclusion criteria
Patients who do not agree with this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Mizowaki |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Radiation Oncology & Image-applied Therapy
Zip code
606-8507
Address
54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL
0757513762
mizo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Mizowaki |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Radiation Oncology & Image-applied Therapy
Zip code
606-8507
Address
54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL
0757513762
Homepage URL
mizo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology & Image-applied Therapy
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0167814016312385?via%3Dihub
Number of participants that the trial has enrolled
Results
Target positions on inspiration phase were underestimated based on the reconstruction from 4DCBCT.
Radiat Oncol. 2018 Apr 19;13(1):73. doi: 10.1186/s13014-018-1019-9.
Radiother Oncol. 2016 Oct;121(1):46-51. doi: 10.1016/j.radonc.2016.07.022.
Epub 2016 Aug 12.
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
| 2014 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 16 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 16 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 16 | Day |
Other
Other related information
Details of the observation:
By acquiring and analyzing 4-dimensional cone-beam CT images, the feasibility of the dynamic tumor-tracking irradiation without implanted fiducial marker will be evaluated.
Management information
Registered date
| 2014 | Year | 08 | Month | 11 | Day |
Last modified on
| 2023 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017206
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
