UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004043 |
|---|---|
| Receipt number | R000004849 |
| Scientific Title | Evaluation of clinical usefulness of PET/CT with aminoacid metabolism |
| Date of disclosure of the study information | 2010/09/01 |
| Last modified on | 2022/08/24 09:04:02 |
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Basic information
Public title
Evaluation of clinical usefulness of PET/CT with aminoacid metabolism
Acronym
Clinical value of methionine-PET/CT
Scientific Title
Evaluation of clinical usefulness of PET/CT with aminoacid metabolism
Scientific Title:Acronym
Clinical value of methionine-PET/CT
Region
| Japan |
Condition
Condition
1.Parathyroid adenoma
2.Multiple myeloma
3.Brain tumor
4.Malignant tumors without FDG avidity
Classification by specialty
| Endocrinology and Metabolism | Hematology and clinical oncology | Radiology |
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish and assess the clinical usefulness of PET/CT with 11C-methionine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic performance
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
| Device,equipment |
Interventions/Control_1
PET/CT scan using 11C-methionine
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
1.Localization of parathyroid adenoma
2.Muliple myeloma
3.Brain tumor after treatment
4.Patients with
Key exclusion criteria
Patients with the following conditions:
1.Communication disturbance
2.Poor clinical status
3.Pregnancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaori Togashi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL
075-751-3760
ktogashi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Nakmoto |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL
075-751-3762
Homepage URL
ynakamo1@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
京都大学病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2010 | Year | 08 | Month | 15 | Day |
Last modified on
| 2022 | 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=R000004849
