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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008523
Receipt No. R000009999
Scientific Title Study of FDG-PET scanning conditions with Discovery-690 PET/CT on healthy volunteers and patients.
Date of disclosure of the study information 2012/07/24
Last modified on 2016/08/24

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Basic information
Public title Study of FDG-PET scanning conditions with Discovery-690 PET/CT on healthy volunteers and patients.
Acronym New-PETCT
Scientific Title Study of FDG-PET scanning conditions with Discovery-690 PET/CT on healthy volunteers and patients.
Scientific Title:Acronym 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
1st name
Middle name
Last name Michio Senda
Organization Institute of Biomedical Research and Innovation
Division name Division of Molecular Imaging
Zip code
Address 2-2,Minatojima-Minamimachi, Chuo-ku, Kobe
TEL 078-304-5212
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kumiko Hirooka
Organization Institute of Biomedical Research and Innovation
Division name Division of Molecular Imaging
Zip code
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)

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 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

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 Completed
Date of protocol fixation
2012 Year 06 Month 08 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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