UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008523 |
|---|---|
| Receipt number | 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 09:19:25 |
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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
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
Sponsor or person
Institute
Institute of Biomedical Research and Innovation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009999
