UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052288 |
|---|---|
| Receipt number | R000059691 |
| Scientific Title | Improving the accuracy of carbon-ion beam dose calculations using stopping power ratios estimated using dual energy CT |
| Date of disclosure of the study information | 2023/10/02 |
| Last modified on | 2025/03/27 14:31:23 |
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Basic information
Public title
Improving the accuracy of carbon-ion beam dose calculations using Dual Energy CT
Acronym
Improving the accuracy of carbon-ion beam dose calculations using Dual Energy CT
Scientific Title
Improving the accuracy of carbon-ion beam dose calculations using stopping power ratios estimated using dual energy CT
Scientific Title:Acronym
Improving the accuracy of carbon-ion beam dose calculations using stopping power ratios estimated using dual energy CT
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To perform DECT imaging at the same time as treatment planning CT imaging for patients undergoing carbon-ion radiotherapy, compare it with conventional methods, examine whether it is possible to reduce range error, and explore its superiority.
Basic objectives2
Others
Basic objectives -Others
Improving the accuracy of carbon-ion beam dose calculations
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dose distribution calculated for Dual Energy CT and Single Energy CT images and dose to OAR and planning target volume in DVH analysis
Key secondary outcomes
Estimated range of each beam calculated for Dual Energy CT and Single Energy CT images and distribution of stopping power ratio for each tissue
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
1) head and neck cancer
2) Be over 20 years old.
3) Performance status (ECOG) is 0-1.
4) Written consent will be obtained from the research subject to participate in this research.
Key exclusion criteria
1) Patients in which metals other than metal markers for treatment have been placed in the body, affecting radiation calculations.
2) Patients that have been judged by a physician, such as a researcher, to be unsuitable for this study due to medical or other reasons.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | SHINOTO |
| Middle name | |
| Last name | MAKOTO |
Organization
National Institutes for Quantum Science and Technology
Division name
QST hospital
Zip code
2638555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
0432063306
shinoto.makoto@qst.go.jp
Public contact
Name of contact person
| 1st name | SHINOTO |
| Middle name | |
| Last name | MAKOTO |
Organization
National Institutes for Quantum Science and Technology
Division name
QST hospital
Zip code
2638555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
0432063306
Homepage URL
shinoto.makoto@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology
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
National Institutes for Quantum Science and Technology
Address
4-9-1 Anagawa, Inage-ku, Chiba
Tel
043-206-4706
helsinki@qst.go.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
| 2023 | Year | 10 | Month | 02 | 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
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 09 | Month | 23 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059691
