UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049862 |
|---|---|
| Receipt number | R000056793 |
| Scientific Title | Evaluation of cardiotoxicity using cardiac MRI in patients treated with IMRT and establishment of cardiac dose constraints |
| Date of disclosure of the study information | 2022/12/26 |
| Last modified on | 2022/12/21 20:35:30 |
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Basic information
Public title
Evaluation of cardiotoxicity using cardiac MRI in patients treated with IMRT and establishment of cardiac dose constraints
Acronym
Evaluation of cardiotoxicity using cardiac MRI in patients treated with IMRT and establishment of cardiac dose constraints
Scientific Title
Evaluation of cardiotoxicity using cardiac MRI in patients treated with IMRT and establishment of cardiac dose constraints
Scientific Title:Acronym
Evaluation of cardiotoxicity using cardiac MRI in patients treated with IMRT and establishment of cardiac dose constraints
Region
| Japan |
Condition
Condition
esophageal cancer, lung cancer, malignant lymphoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to demonstrate the effects of radiotherapy (conventional irradiation, IMRT) on cardiac toxicity using cardiac MRI in patients treated with radiotherapy for malignant tumors in the thoracic region.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MR strain, Native T1
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Cardiac MRI examinations will be performed 3 times in total: before radiotherapy, 4 months after radiotherapy, and 1 year after radiotherapy.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Performance status 0-1, patients with written informed consent, patients for whom MRI examination can be safely performed
Key exclusion criteria
Patients with a history of ischemic heart disease, patients with abnormal signals of heart disease in cardiac MRI before radiotherapy, patients with a history of radiotherapy to the chest, patients with uncontrolled diabetes and hypertension
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Tsuruoka |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Radiology
Zip code
791-0295
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5371
tsuruoka.shintaro.az@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Tsuruoka |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Radiology
Zip code
791-0295
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5371
Homepage URL
tsuruoka.shintaro.az@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Ehime University Hospital
Address
454 Shitsukawa, Toon, Ehime
Tel
089-964-5111
tsuruoka.shintaro.az@ehime-u.ac.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 | 26 | 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
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 21 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056793
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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