UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055447 |
|---|---|
| Receipt number | R000063356 |
| Scientific Title | Research on cardiac dysfunction after carbon-ion radiotherapy |
| Date of disclosure of the study information | 2024/09/09 |
| Last modified on | 2024/09/06 16:20:00 |
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Basic information
Public title
Research on cardiac dysfunction after carbon-ion radiotherapy
Acronym
Research on cardiac dysfunction after carbon-ion radiotherapy
Scientific Title
Research on cardiac dysfunction after carbon-ion radiotherapy
Scientific Title:Acronym
Research on cardiac dysfunction after carbon-ion radiotherapy
Region
| Japan |
Condition
Condition
Esophageal cancer, Hepatocellular carcinoma, Intrahepatic bile duct cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the effects on the heart when the heart is included in the irradiation field in carbon-ion radiotherapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of Grade 3 or higher cardiac adverse events occurring between 3 and 24 months after the end of carbon-ion radhiotherapy
Key secondary outcomes
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) Persons aged 18 or over at the time of obtaining consent. Gender is not a consideration.
2) Those who have been diagnosed with esophageal cancer, hepatocellular carcinoma, or intrahepatic bile duct cancer and will undergo carbon ion radiotherapy.
3) Those who are expected to have their heart included in the irradiation field, as described in 2).
4) Those who can regularly visit QST Hospital for at least two years after the end of carbon ion beam irradiation.
5) Those who are judged by the researcher to be able to understand the consent document.
Key exclusion criteria
1) People who cannot have an MRI scan due to claustrophobia, pacemakers, or magnetic metals in the body.
2) People with a history of contrast agent allergies, or people with low kidney function who cannot have a contrast MRI scan.
3) People with serious complications, or people who have a history of these complications and who are judged by the researcher to be unsuitable for this study.
4) Those who are pregnant or may be pregnant, or who are breastfeeding.
5) Others who are judged by the researcher to be unsuitable as a research subject.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Isozaki |
Organization
National Institutes for Quantum Science and Technology QST Hospital
Division name
Department of Radiology
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3306
isozaki.tetsuro@qst.go.jp
Public contact
Name of contact person
| 1st name | Tetsuro |
| Middle name | |
| Last name | Isozaki |
Organization
National Institutes for Quantum Science and Technology QST Hospital
Division name
Department of Radiology
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3306
Homepage URL
isozaki.tetsuro@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
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
043-206-3306
isozaki.tetsuro@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
| 2024 | Year | 09 | Month | 09 | 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
| 2024 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2024 | Year | 09 | Month | 06 | Day |
Last modified on
| 2024 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063356
