UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022196 |
|---|---|
| Receipt number | R000025559 |
| Scientific Title | Evaluation of the image quality and the quantitative accuracy of PET images obtained from the flexible PET device |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2017/05/04 11:01:31 |
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Basic information
Public title
Evaluation of the image quality and the quantitative accuracy of PET images obtained from the flexible PET device
Acronym
Evaluation of the image quality and the quantitative accuracy of PET images obtained from the flexible PET device
Scientific Title
Evaluation of the image quality and the quantitative accuracy of PET images obtained from the flexible PET device
Scientific Title:Acronym
Evaluation of the image quality and the quantitative accuracy of PET images obtained from the flexible PET device
Region
| Japan |
Condition
Condition
Malignant tumors except for early gastric cancer
Epilepsy
Cardiac sarcoidosis
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The flexible PET device (fxPET), which allows us to fit a bed of imaging modalities and patients of various body sizes, has been developed. The purpose of this study is to evaluate the quantitative accuracy and image quality of fxPET images with attenuation correction performed by means of CT data obtained from whole-body PET/CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The quantitative accuracy will be assessed by evaluating the relationship between the standardized uptake values (SUVs) of fxPET and those of whole-body PET/CT.
Key secondary outcomes
The image quality of fxPET images will be analysed visually by two board-certified nuclear medicine physicians by means of a 4-point grading scale.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients, who are suspected malignancy, undergo a whole-body PET/CT scan, and an additional scan by fxPET.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who are going to undergo the PET/CT with applied health insurance and agree to sign the written consent form of the study
2)Patients who are over 20 years of age and more when they are registered in the study
Key exclusion criteria
1) Patients who disagree to take part in the study
2) Patients who are under 20 years old
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Togashi Kaori |
Organization
Kyoto University
Division name
Department of Diagnostic Imaging and Nuclear Medicine Graduate School of Medicine
Zip code
Address
54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto-city
TEL
075-751-3760
ktogashi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryusuke Nakamoto |
Organization
Kyoto University
Division name
Department of Diagnostic Imaging and Nuclear Medicine Graduate School of Medicine
Zip code
Address
54, Shogoin Kawahara-cho, Sakyo-ku, Kyoto-city
TEL
075-751-3760
Homepage URL
inabook@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | 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
| 2016 | Year | 05 | Month | 03 | Day |
Last modified on
| 2017 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025559
