UMIN-CTR Clinical Trial

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
Email	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
Email	reirei513@hotmail.com

Sponsor
Institute	Department of Radiation Oncology, Tohoku University, Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037126