UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007966
Receipt number R000009373
Scientific Title Prospective study for the early detection of radiation-induced myocarial damage by nuclear medicine diagnostic imaging
Date of disclosure of the study information 2012/07/01
Last modified on 2017/12/09 10:35:57

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Basic information

Public title

Prospective study for the early detection of radiation-induced myocarial damage by nuclear medicine diagnostic imaging

Acronym

Early detection of the radiation-induced myocardial damage by nuclear medicine

Scientific Title

Prospective study for the early detection of radiation-induced myocarial damage by nuclear medicine diagnostic imaging

Scientific Title:Acronym

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

1st name
Middle name
Last name Kentaro Takanami

Organization

Tohoku University Hospital

Division name

Department of Radiology

Zip code


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

1st name
Middle name
Last name Kentaro Takanami

Organization

Tohoku University Hospital

Division name

Department of Radiology

Zip code


Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7312

Homepage URL


Email

takanami@rad.med.tohoku.ac.jp


Sponsor or person

Institute

Department of Radiology, 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


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://www.sciencedirect.com/science/article/pii/S0167814016000554?via%3Dihub

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

Main results already published

Date of protocol fixation

2012 Year 06 Month 30 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009373


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name