UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study for the early detection of radiation-induced myocarial damage by nuclear medicine diagnostic imaging
Title of the study (Brief title)	Early detection of the radiation-induced myocardial damage by nuclear medicine
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 the effect of radiation given to myocardial energy metabolism. 2. To develop new methods for the early detection of radiation-induced myocardial damage by nuclear medicine diagnostic imaging.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Confirm the relationship between BMIPP uptake and irradiation dose of the left ventricular myocardium with respect to each segment of the myocardium.
Key secondary outcomes	Clarify the relationship between the decrease of myocardial BMIPP uptake after irradiation and the subsequent cardiac events.

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 July 2012 and December 2015, the subjects will undergo nuclear medicine inspection before, 3 month after and 12 months after the completion of radiation therapy. Inspection methods: After administration of I-123 BMIPP, radioactive drug, 111MBq, SPECT/CT (nuclear medicine diagnostic equipment) will be scanned.
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	Esophageal cancer has been diagnosed by pathological examination. There is a radical adaptation of irradiation (No distant metastases). Fair ggeneral condition (PS below 2) No history of heart disease. There is written consent of the patient.
Key exclusion criteria	History of heart disease History of radiation to the mediastinum Under 20 year old Lactating or pregnant women
Target sample size	30

Research contact person
Name of lead principal investigator	Kentaro Takanami
Organization	Tohoku University Hospital
Division name	Department of Radiology
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7312
Email	takanami@rad.med.tohoku.ac.jp

Public contact
Name of contact person	Kentaro Takanami
Organization	Tohoku University Hospital
Division name	Department of Radiology
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7312
Homepage URL
Email	takanami@rad.med.tohoku.ac.jp

Sponsor
Institute	Department of Radiology, 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)

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	2012 Year 07 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 06 Month 30 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://www.sciencedirect.com/science/article/pii/S0167814016000554?via%3Dihub
Results
Other related information

Management information
Registered date	2012 Year 05 Month 16 Day
Last modified on	2017 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009373