UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040015 |
|---|---|
| Receipt number | R000045615 |
| Scientific Title | The assessment of lesion detection capability and FDG uptake value by digital PET/CT |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2024/03/27 00:44:50 |
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Basic information
Public title
The assessment of lesion detection capability and FDG uptake value by digital PET/CT
Acronym
The assessment of lesion detection capability and FDG uptake value by digital PET/CT
Scientific Title
The assessment of lesion detection capability and FDG uptake value by digital PET/CT
Scientific Title:Acronym
The assessment of lesion detection capability and FDG uptake value by digital PET/CT
Region
| Japan |
Condition
Condition
Malignancy, vasculitis, cardiac sarcoidosis, etc.
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare lesion detection capability and differences in quantitative values such as standardized uptake value(SUV) between a digital and an analog PET/CT system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lesion detection capability
Key secondary outcomes
SUVmax of the lesions and Physiological Accumulation,image quality
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 receive an intravenous administration of FDG as in the usual PET scan.
Patients undergo the digital PET/CT scan (Discovery Mi-AM edition, GE Healthcare) and the analog PET scan (Discovery 600 PET/CT, GE Healthcare) 60 minutes after FDG administration.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who obtained written consent before PET/CT.
Key exclusion criteria
1) Patients who have difficulty remaining still during PET/CT scan.
2) Patients who have undergone multiple PET/CT scans by the same imaging protocol during the study period and have already been included in this study.
3) Other patients who are judged to be unsuitable for this study by the study physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Kawaguchi |
Organization
Ehime University graduate school of medicine
Division name
Department of radiology
Zip code
791-0204
Address
Ehime Prefecture Toon City Shitsukawa
TEL
089-964-5111
n.kawa1113@gmail.com
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Kawaguchi |
Organization
Ehime University graduate school of medicine
Division name
Department of radiology
Zip code
791-0204
Address
Ehime Prefecture Toon City Shitsukawa
TEL
089-964-5111
Homepage URL
n.kawa1113@gmail.com
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Ehime University
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
Institutional Review Board ,Ehime University Hospital
Address
Shitsukawa, Toon, Ehime, Japan
Tel
089-960-5914
rinri@m.ehime-u.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
| 2020 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2020 | Year | 03 | Month | 31 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045615
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
