UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018670 |
|---|---|
| Receipt number | R000021594 |
| Scientific Title | A study on differential diagnosis of radiation necrosis and brain tumor recurrence with dual stage Methionine PET/CT |
| Date of disclosure of the study information | 2015/08/14 |
| Last modified on | 2018/03/31 17:47:41 |
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Basic information
Public title
A study on differential diagnosis of radiation necrosis and brain tumor recurrence with dual stage Methionine PET/CT
Acronym
Dual stage Methionine PET/CT
Scientific Title
A study on differential diagnosis of radiation necrosis and brain tumor recurrence with dual stage Methionine PET/CT
Scientific Title:Acronym
Dual stage Methionine PET/CT
Region
| Japan |
Condition
Condition
brain tumor recurrence and radiation necrosis
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To make accuracy, sensitivity, specificity higher by adding delayed image of methionine PET.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Which is more accurate, the conclusion from early image only and the conclusion from both early image and delayed image are compared.
The answer is acquired by the course or the pathology.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who undergoes methionine PET/CT to determine whether radiation necrosis or brain tumor recurrence
Key exclusion criteria
patients who do not agree to participate
patients who have difficulty in stopping moving
other patients whom researcher (doctor) judged to exclude.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Kameyama |
Organization
National Center for Global Health and Medicine
Division name
Division of Nuclear Medicine
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan, 162-8655
TEL
03-5273-6881
kame-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Kameyama |
Organization
National Center for Global Health and Medicine
Division name
Division of Nuclear Medicine
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan, 162-8655
TEL
03-5273-6881
Homepage URL
kame-tky@umin.ac.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
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
| 2015 | Year | 08 | Month | 14 | 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
| 2014 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
under observation
Management information
Registered date
| 2015 | Year | 08 | Month | 14 | Day |
Last modified on
| 2018 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021594
