UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038147 |
|---|---|
| Receipt number | R000043481 |
| Scientific Title | A prospective study about the detection myocardial damage after intensity-modulated radiotherapy using cardiac magnatic resonance imaging |
| Date of disclosure of the study information | 2019/09/30 |
| Last modified on | 2019/09/30 09:31:46 |
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Basic information
Public title
A prospective study about the detection myocardial damage after intensity-modulated radiotherapy using cardiac magnatic resonance imaging
Acronym
A prospective study of myocardial changes after intensity-modulated radiation therapy
Scientific Title
A prospective study about the detection myocardial damage after intensity-modulated radiotherapy using cardiac magnatic resonance imaging
Scientific Title:Acronym
A prospective study of myocardial changes after intensity-modulated radiation therapy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this prospective study is to observe myocardial damage after intensity-modulated radiation therapy for esophageal cancer using cardiac magnatic resonance imaging.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of myocardial changes on cardiac MRI six months after intensity-modulated radiation therapy
Key secondary outcomes
Cumulative incidence of cardiac accident after intensity modulated radiation therapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Cardiac MRI is performed before and 6 mpnths after intensity-modulated 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
(1) Esophageal cancer diagnosed histologically by biopsy.
(2) Cases scheduled for definitive radiation therapy with T1N0M0 (UICC-TNM 8th edition).
(3) Cases in which a part of the heart is assumed to be included in the radiation field.
(4) Eastern Cooperative Oncology Group performance status, 0-1.
(5) Normal kidney function (estimated glomerular filtration rate [eGFR] > 30 ml/min/1.73m2).
(6) There is written consent of the patient.
Key exclusion criteria
(1) Cases with heart disease and hypertension taking ACE inhibitor / ARB.
(2) Cases with serious complications other than heart disease (uncontrolled lung / liver / kidney disease, diabetes, collagen disease, intestinal obstruction, active ulcer of the digestive tract, etc.).
(3) Cases with active malignancy other than esophageal cancer.
(4) Cases with a history of chemotherapy.
(5) Cases with history of mediastinal irradiation.
(6) Cases scheduled for radiation therapy alone
(7) Female during pregnancy, within 28 days of postparturition, or during lactation
(8) Cases with pacemakers or internal metal implants
(9) Claustrophobia
(10) Severe psychological disorder.
Target sample size
20
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
| 2019 | Year | 09 | Month | 30 | 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
| 2019 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2019 | Year | 09 | Month | 29 | Day |
Last modified on
| 2019 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043481
