UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043481