UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of FDG-PET scanning conditions with Discovery-690 PET/CT on healthy volunteers and patients.
Title of the study (Brief title)	New-PETCT
Region	Japan

Condition
Condition	1)Normal healthy volunteer 2)Patients with or suspected of cancer who undergo diagnostic FDG-PET scan.
Classification by specialty	Radiology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate image quality of FDG PET using the new PET/CT (Discovery-690) scanner with a variety of new features of data acquisition.
Basic objectives2	Others
Basic objectives -Others	For healthy volunteers, FDG is injected and PET scan is performed with Discovery-690 using various data acquisition protocols. For patients, PET scan is performed with Discovery-690 just after they have finished routine diagnostic FDG PET/CT scan with Discovery-STEP.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1)Evaluation of image quality based on the Society Guideline. 2)Comparison of PET images with those acquired in routine clinical scan.
Key secondary outcomes

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	FDG-PET/CT scan with Discovery-690 scanner.
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	30 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy voulunteer (n=12) 1)Informed concent is obtained. 2)Healthy voulunteer. Patients (n=12) 1)Consent of the referring physician. 2)Informed concent is obtained.
Key exclusion criteria	Healthy voulunteer: 1)Cannot keep the supine position for 60 minutes. 2)Possibility of incomplete scan. 3)Unable to fast for six hours before the PET. 4)Substantial radiation exposure besides this study. 5)Possibility of pregnancy. 6)Subjects for diagnostic PET scan covered by insurance. 7)Regarded as unsuitable by investigators. For patients: 1)Scheduled to undergo contrast enhanced CT after rotine PET/CT. 2)Scheduled to undergo delayed scan as rotine PET/CT 3)Cannot keep the supine position for 35 minutes. 4)Possibility of incomplete scan. 5)Regarded as unsuitable by investigator.
Target sample size	24

Research contact person
Name of lead principal investigator	Michio Senda
Organization	Institute of Biomedical Research and Innovation
Division name	Division of Molecular Imaging
Address	2-2,Minatojima-Minamimachi, Chuo-ku, Kobe
TEL	078-304-5212
Email

Public contact
Name of contact person	Kumiko Hirooka
Organization	Institute of Biomedical Research and Innovation
Division name	Division of Molecular Imaging
Address	2-2,Minatojima-Minamimachi, Chuo-ku, Kobe
TEL	078-304-5212
Homepage URL
Email

Sponsor
Institute	Institute of Biomedical Research and Innovation
Institute
Department

Funding Source
Organization	Foundation of Biomedical Research and Innovation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	先端医療センター（兵庫県）

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 08 Day
Anticipated trial start date	2012 Year 07 Month 24 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 07 Month 24 Day
Last modified on	2016 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009999