UMIN-CTR Clinical Trial

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
Email	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
Email	mioko.yoshida.b8@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049016