UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038174 |
|---|---|
| Receipt number | R000043514 |
| Scientific Title | Retrospective study to assess diagnostic ability of IMP SPECT imaging and its fusion images with CT or MRI in patients with choroidal tumors in terms of the prediction of early treatment response after carbon ion radiotherapy |
| Date of disclosure of the study information | 2019/10/03 |
| Last modified on | 2022/10/03 09:33:52 |
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Basic information
Public title
Retrospective study to assess diagnostic ability of IMP SPECT imaging and its fusion images with CT or MRI in patients with choroidal tumors in terms of the prediction of early treatment response after carbon ion radiotherapy
Acronym
Retrospective study to assess diagnostic ability of IMP SPECT imaging and its fusion images with CT or MRI in patients with choroidal tumors
Scientific Title
Retrospective study to assess diagnostic ability of IMP SPECT imaging and its fusion images with CT or MRI in patients with choroidal tumors in terms of the prediction of early treatment response after carbon ion radiotherapy
Scientific Title:Acronym
Retrospective study to assess diagnostic ability of IMP SPECT imaging and its fusion images with CT or MRI in patients with choroidal tumors
Region
| Japan |
Condition
Condition
Choroidal tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess IMP SPECT imaging for accurate diagnosis before and after carbon ion radiotherapy in patients with choroidal tumors.
1) Usefulness of IMP SPECT imaging and its fusion images with CT or MRI.
2) Usefulness of IMP SPECT semi-quantitative evaluation method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Usefulness of IMP-SPECT imaging and its fusion images with CT or MRI, and IMP SPECT semi-quantitative evaluation method.
1) diagnostic ability of choroidal tumor, 2) local control rate, and 3) disease-free recurrence period.
Key secondary outcomes
Correlation among semi-quantitative evaluation methods such as SUV of IMP SPECT, tumor size, and the presence or absence of distant metastasis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were performed IMP SPECT and CT or MRI for choroidal tumor treatment, among who were / will be treated with carbon ion radiotherapy for choroidal tumors from November 2017 to March 2021 at QST hospital.
Key exclusion criteria
1. Other cause of death within 12 months after carbon ion radiotherapy.
2. Patients who were received other anticancer treatments within 4 months after carbon ion radiotherapy.
3. Patients who refuse to participate in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryuichi |
| Middle name | |
| Last name | Nishii |
Organization
National Institute of Radiological Sciences (NIRS), QST
Division name
Dept. of Molecular Imaging and Theranostics
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-4074
nishii.ryuichi@qst.go.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Yamazaki |
Organization
National Institute of Radiological Sciences (NIRS), QST
Division name
Dept. of Molecular Imaging and Theranostics
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-4076
Homepage URL
yamazaki.kana@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences (NIRS), QST
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
Certified Review Board, QST
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
| 2019 | Year | 10 | Month | 03 | 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
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | 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
| 2019 | Year | 10 | Month | 01 | Day |
Last modified on
| 2022 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043514
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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