UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049770 |
|---|---|
| Receipt number | R000056686 |
| Scientific Title | Retrospective study of liver reserve capacity evaluation using GSA SPECT and MRI in patients with liver tumor treated by carbon ion radiotherapy, Mid- to long-term follow-up study |
| Date of disclosure of the study information | 2022/12/14 |
| Last modified on | 2022/12/14 09:33:44 |
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Basic information
Public title
Retrospective study of liver reserve capacity evaluation using GSA SPECT and MRI in patients with liver tumor treated by carbon ion radiotherapy, Mid- to long-term follow-up study
Acronym
Retrospective study of liver reserve capacity evaluation using GSA SPECT and MRI in patients with liver tumor treated by carbon ion radiotherapy, Mid- to long-term follow-up study
Scientific Title
Retrospective study of liver reserve capacity evaluation using GSA SPECT and MRI in patients with liver tumor treated by carbon ion radiotherapy, Mid- to long-term follow-up study
Scientific Title:Acronym
Retrospective study of liver reserve capacity evaluation using GSA SPECT and MRI in patients with liver tumor treated by carbon ion radiotherapy, Mid- to long-term follow-up study
Region
| Japan |
Condition
Condition
Liver tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore methods and predictive value factors for assessing hepatic reserve in the mid-to-long term after heavy ion therapy for liver tumors using GSA SPECT and MRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of diagnostic abilities of GSA SPECT or MRI in terms of prediction of residual liver reserve capacity before and 3 months, 1 to 5 years after carbon ion radiotherapy
Key secondary outcomes
Correlation among overall survival rate, treatment completion rate in intent to treat group, liver function indices such as Child-Pugh classification and other clinical data, and radiation dosimetry estimation.
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 underwent GSA SPECT and MRI among those who were / will be treated with carbon ion radiotherapy for liver tumors from December 2018 to September 2024 at QST hospital.
Key exclusion criteria
Patients who refuse to participate in this study. However, if the request is made after the opt-out period and the data has already been used for analysis, it may not be excluded.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kana |
| Middle name | |
| Last name | Yamzaki |
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology (QST)
Division name
Dept. of Molecular Imaging and Theranostics
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba, Japan
TEL
043-206-3402
yamazaki.kana@qst.go.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Yamazaki |
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Instit
Division name
Dept. of Molecular Imaging and Theranostics
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba, Japan
TEL
043-206-3402
Homepage URL
yamazaki.kana@qst.go.jp
Sponsor or person
Institute
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology (QST)
Institute
Department
Personal name
Funding Source
Organization
Institute for Quantum Medical Science, Quantum Life and Medical Science Directorate, National Institutes for Quantum Science and Technology (QST)
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
Certifi ed Review Board, QST
Address
4-9-1 Anagawa, Inage-ku, Chiba, Japan
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
| 2022 | Year | 12 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2022 | Year | 12 | Month | 13 | Day |
Last modified on
| 2022 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056686
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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