UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005838 |
|---|---|
| Receipt number | R000006841 |
| Scientific Title | Assessment of cell proliferation using FLT-PET for FDG-avid parotid tumor |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2016/08/24 09:13:06 |
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Basic information
Public title
Assessment of cell proliferation using FLT-PET for FDG-avid parotid tumor
Acronym
FLT-PET for FDG-avid parotid tumor
Scientific Title
Assessment of cell proliferation using FLT-PET for FDG-avid parotid tumor
Scientific Title:Acronym
FLT-PET for FDG-avid parotid tumor
Region
| Japan |
Condition
Condition
Parotid tumor
Classification by specialty
| Oto-rhino-laryngology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical value of FLT-PET for the patients with FDG-avid parotid tumor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between FLT uptake and clinical diagnosis / FDG uptake
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
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
FLT-PET
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
1. FDG-PET was performed within 2 months before entering this study
2. FDG-avid parotid tumor was pointed out, and examined at otorhinolaryngology department of KCMCGH
3. Diameter of the parotid tumor was 1cm or more confirmed by CT / MRI / US
4. Patients understood well their condition of the disease
Key exclusion criteria
1. Poor general condition
2. Cannot keep supine position for 60 minutes
3. Pregnant or possibility of pregnancy
4. Severe claustrophobia
5. Regarded as unsuitable by responsible investigators
Target sample size
10
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Institute of Biomedical Research and Innovation
Division name
Division of Molecular Imaging
Zip code
Address
2-2, Minatojima-Minamimachi, Chuo-Ku, Kobe
TEL
078-306-1700
Homepage URL
Sponsor or person
Institute
Foundation 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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
| 2011 | Year | 06 | Month | 23 | 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=R000006841
