UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020945 |
|---|---|
| Receipt number | R000024168 |
| Scientific Title | Prospective investigation of C-11 methionine PET/CT for bone tumor |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2018/03/26 20:15:01 |
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Basic information
Public title
Prospective investigation of C-11
methionine PET/CT for bone tumor
Acronym
Prospective investigation of C-11
methionine PET/CT for bone tumor
Scientific Title
Prospective investigation of C-11
methionine PET/CT for bone tumor
Scientific Title:Acronym
Prospective investigation of C-11
methionine PET/CT for bone tumor
Region
| Japan |
Condition
Condition
Bone tumor
Classification by specialty
| Orthopedics | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this prospective study is
to assess the amino acid metabolism in bone tumor and internal organs
with C-11 methionine PET/CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation between C-11 methionine
uptake to the bone tumor and histological findings.
Key secondary outcomes
The comparison between C-11
methionine PET/CT and other imaging
modalities in patients with bone tumor.
The assessment of the C-11 methionine
uptake to internal organs with multiple-time-point PET/CT.
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 |
Interventions/Control_1
Preoperative examination of C-11
methionine PET/CT(C-11 methionine 3.7MBq/kg)(until March 31, 2022)
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
| 3 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with suspected bone tumor who are to be operated.
Key exclusion criteria
Baby and toddler (under 3 years olds).
Pregnant female.
Nursing woman.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Harada |
Organization
Tokushima university hospital
Division name
Department of Radiology
Zip code
Address
Kuramotocho 2-50-1, Tokushima-city
TEL
088-633-7173
shinya.takayoshi@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Otomi |
Organization
Tokushima university hospital
Division name
Department of Radiology
Zip code
Address
Kuramotocho 2-50-1, Tokushima-city
TEL
088-633-7173
Homepage URL
otomi.yoichi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima university hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
徳島大学病院(徳島県)
Other administrative information
Date of disclosure of the study information
| 2016 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 08 | Day |
Last modified on
| 2018 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024168
