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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
