UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032551 |
|---|---|
| Receipt number | R000037126 |
| Scientific Title | The prospective study about the detection of myocardial damage after radiotherapy using cardiac magnatic resonance imaging |
| Date of disclosure of the study information | 2018/05/11 |
| Last modified on | 2022/05/14 10:49:46 |
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Basic information
Public title
The prospective study about the detection of myocardial damage after radiotherapy using cardiac magnatic resonance imaging
Acronym
The prospective study about radiation-induced myocardial damage using cardiac magnatic resonance imaging
Scientific Title
The prospective study about the detection of myocardial damage after radiotherapy using cardiac magnatic resonance imaging
Scientific Title:Acronym
The prospective study about radiation-induced myocardial damage using cardiac magnatic resonance imaging
Region
| Japan |
Condition
Condition
Esophageal Cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is
1. To clarify myocardial changes (fibrosis) after radiotherapy using cardiac MRI.
2. To make early detection of radiation-induced heart disease and to apply these results to the future radiation plan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confirm late gadolinium enhancement (myocardial fibrosis) corresponding to radiation field 6 months and 1.5 years after radiotherapy and evaluate the correlations between radiation dose and myocardial fibrosis.
Key secondary outcomes
Examine the relationships between the frequency of cardiac events and myocardial changes.
Evaluate the correlations between the results of other examinations such as electrocardiography and myocardial changes.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Between Janualy 2013 and June 2016, the subjects will undergo cardiac MRI before, 6 month after and 1.5 years after the completion of radiation therapy.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases in which there is a radical adaptation of irradiation and long-term survival could be expected.
Eastern Cooperative Oncology Group performance status, 0-1.
Normal kidney function (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m2).
There is written consent of the patient.
Key exclusion criteria
Cases in which the myocardium was expected to be included in radiation field.
Other active malignancy at the start of our study.
History of mediastinal radiotherapy.
History of chemotherapy.
History of heart disease.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Rei |
| Middle name | |
| Last name | Umezawa |
Organization
Tohoku University Hospital
Division name
Department of Radiation Oncology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7312
reirei513@hotmail.com
Public contact
Name of contact person
| 1st name | Rei |
| Middle name | |
| Last name | Umezawa |
Organization
Tohoku University Hospital
Division name
Department of Radiation Oncology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7312
Homepage URL
reirei513@hotmail.com
Sponsor or person
Institute
Department of Radiation Oncology, Tohoku 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
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
| 2018 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
23
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2018 | Year | 05 | Month | 11 | Day |
Last modified on
| 2022 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037126
