UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061358 |
|---|---|
| Receipt number | R000070114 |
| Scientific Title | Accuracy verification study of a non-invasive eye positioning system in carbon ion radiotherapy for choroidal melanoma |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/23 10:17:54 |
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Basic information
Public title
Accuracy verification study of a non-invasive eye positioning system in carbon ion radiotherapy for choroidal melanoma
Acronym
Accuracy verification study of eye positioning system in carbon ion radiotherapy
Scientific Title
Accuracy verification study of a non-invasive eye positioning system in carbon ion radiotherapy for choroidal melanoma
Scientific Title:Acronym
Accuracy verification study of eye positioning system in carbon ion radiotherapy
Region
| Japan |
Condition
Condition
Choroidal melanoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the accuracy of eye positioning using the iris, rather than metal markers.
Basic objectives2
Others
Basic objectives -Others
accuracy verification
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Displacement between marker matching and iris matching.
Key secondary outcomes
Setup time; feasibility rate of iris matching during treatment planning CT.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with choroidal melanoma who have undergone metal marker suturing
2. can follow medical instructions
3. have provided written consent.
Key exclusion criteria
Patients who cannot remain still.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Wakatsuki |
Organization
National Institutes for Quantum Science and Technology
Division name
QST Hospital
Zip code
2638555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
TEL
043-206-3306
wakatsuki.masaru@qst.go.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Makishima |
Organization
National Institutes for Quantum Science and Technology
Division name
QST Hospital
Zip code
2638555
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
TEL
043-206-3306
Homepage URL
makishima.hirokazu@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
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yonsei University, South Korea
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-shi, Chiba
Tel
043-206-3306
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
| 2026 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The displacement of the iris center calculated from the displacement during marker matching and the displacement from iris matching will be compared in the vertical (craniocaudal) and horizontal (left-right) directions, respectively, and correlation coefficients will be calculated.
Management information
Registered date
| 2026 | Year | 04 | Month | 23 | Day |
Last modified on
| 2026 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070114
