UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062039 |
|---|---|
| Receipt number | R000070988 |
| Scientific Title | Development of Beam Imaging Technology for Scanning Irradiation in Heavy Ion Radiotherapy |
| Date of disclosure of the study information | 2026/06/24 |
| Last modified on | 2026/06/24 11:04:38 |
* 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
Development of Beam Imaging Technology for Scanning Irradiation in Heavy Ion Radiotherapy
Acronym
Development of Beam Imaging Technology for Scanning Irradiation in Heavy Ion Radiotherapy
Scientific Title
Development of Beam Imaging Technology for Scanning Irradiation in Heavy Ion Radiotherapy
Scientific Title:Acronym
Development of Beam Imaging Technology for Scanning Irradiation in Heavy Ion Radiotherapy
Region
| Japan |
Condition
Condition
Choroidal malignant melanoma.
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
During heavy ion beam irradiation of a patient, secondary electron bremsstrahlung emitted from within the patient is measured two-dimensionally using a newly developed SEB imaging device by QST (Takasaki Advanced Radiation Research Institute). This enables visualization of the beam's range within the body. By performing time-resolved measurements during scanning irradiation, changes in the beam's arrival position can be monitored.
Basic objectives2
Others
Basic objectives -Others
Measurement of Particle Beam Irradiation Field Using a Secondary Electron Bremsstrahlung Imaging System
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of Irradiation Field in Patients with Choroidal Malignant Melanoma Using a Secondary Electron Bremsstrahlung (SEB) Imaging System
Key secondary outcomes
Estimation of Treatment Beam Range Based on Two-Dimensional Measurement of Irradiation Energy and Secondary Electron Bremsstrahlung
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older with choroidal malignant melanoma who are scheduled to undergo heavy ion radiotherapy, and from whom informed consent has been obtained.
Key exclusion criteria
Individuals deemed unsuitable for participation in this study by the principal investigator or other responsible physicians due to medical or other reasons.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Wakatsuki |
Organization
National Institutes
for Quantum Science and Technology (QST)
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3360
wakatsuki.masaru@qst.go.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Wakatsuki |
Organization
National Institutes for Quantum Science and Technology (QST)
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3360
Homepage URL
wakatsuki.masaru@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology (QST)
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology (QST)
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
National Institutes for Quantum Science and Technology (QST)
Address
4-9-1 Anagawa, Inage-ku, Chiba
Tel
043-206-3360
wakatsuki.masaru@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
| 2026 | Year | 06 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A study targeting patients with choroidal malignant melanoma undergoing heavy ion radiotherapy at QST Hospital, in which an imaging system is used during treatment to verify the irradiation field of the heavy ion beam.
Management information
Registered date
| 2026 | Year | 06 | Month | 24 | Day |
Last modified on
| 2026 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070988
