UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042941 |
|---|---|
| Receipt number | R000049016 |
| Scientific Title | Prospective study on the association between myocardial accumulation and heart disease in FDG PET for tumor diagnosis Myocardial Accumulation and Heart Disease in FDG PET for Tumor Diagnosis |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2021/02/25 11:44:14 |
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Basic information
Public title
A study to clarify the relationship between FDG PET findings and heart disease for the purpose of tumor diagnosis
Acronym
Association between Tumor FDG PET Findings and Heart Disease
Scientific Title
Prospective study on the association between myocardial accumulation and heart disease in FDG PET for tumor diagnosis
Myocardial Accumulation and Heart Disease in FDG PET for Tumor Diagnosis
Scientific Title:Acronym
A Prospective Study on the Association between Tumor FDG PET Findings and Heart Disease
Region
| Japan |
Condition
Condition
Ischemic heart disease.
Classification by specialty
| Psychosomatic Internal Medicine | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are many overlapping risk factors for carcinogenesis and ischemic heart disease, such as smoking and aging. The purpose of this study was to establish a screening method for heart disease using 18F-fluorodeoxyglucose Positron Emission Tomography (FDG PET), a nuclear medicine test for tumor diagnosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare myocardial FDG accumulation patterns with the results of cardiac examinations to identify cardiac FDG accumulation patterns that are predictive of heart disease.
Key secondary outcomes
Myocardial FDG accumulation is known to be affected by fasting time and diet prior to FDG PET examination, and the optimal pre-test conditions will be discussed.
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
Myocardial perfusion scintigraphy
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Men and women over 60 years old
(2) Scheduled to undergo FDG PET examination as a pre-treatment test for esophageal cancer or lung cancer.
(3) Have at least 3 of the following coronary risk factors (male, hypertension(systolic blood pressure >=130 mmHg), type 2 diabetes mellitus, hypertriglyceridemia (TG >=150 mg/dL), hypoHDLemia (HDL<40 mg/dL), smoking history, obesity (BMI>=25)).
(4) The contents of this study will be explained in writing and orally, and the subject will understand and give written consent.
(5) Good general health (PS2 or less)
Key exclusion criteria
(1) History of thoracic surgery or radiation to the chest
(2) Difficult to perform stress myocardial perfusion scintigraphy before treatment for esophageal cancer due to schedule
(3) Patients who are not eligible for PET scan or stress myocardial scintigraphy in their regular practice
Pregnancy and lactation: Pregnant and lactating women, or those who may be pregnant.
History of adverse reaction or allergy related to FDG administration in the past 18F-FDG-PET examination.
Prior history of adverse reactions or allergies related to drugs used in myocardial perfusion scintigraphy.
Treatment for unstable angina, complete atrioventricular block, or asthma
(4) Chest pain suggestive of angina pectoris.
(5) Previously indicated coronary artery stenosis of 90% or more by coronary CT and untreated
(6) Other conditions considered difficult to participate in the study
Difficulty in resting on a bed for 30 minutes
Inability to understand the content of the study due to psychosis or psychiatric symptoms
Patients who fall into any of the above categories are not eligible for the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | takanami |
Organization
Tohoku University Hospital
Division name
Department of Diagnostic Radiology
Zip code
980-8574
Address
Seiryo-cho 1-1, Aoba-ku, Sendai-city
TEL
022-717-7312
takanami@rad.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Mioko |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University Hospital
Division name
Department of Diagnostic Radiology
Zip code
980-8574
Address
Seiryo-cho 1-1, Aoba-ku, Sendai-city
TEL
022-717-7312
Homepage URL
mioko.yoshida.b8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Hospital
Address
Seiryo-cho 1-1, Aoba-ku, Sendai City
Tel
022-717-3964
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
| 2021 | Year | 04 | Month | 01 | 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
| 2021 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 04 | 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
| 2021 | Year | 01 | Month | 07 | Day |
Last modified on
| 2021 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049016
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