UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024072 |
|---|---|
| Receipt number | R000027718 |
| Scientific Title | Molecular Imaging using amino-acid PET tracer: Clinical research for diagnostic and therapeutic evaluation with amino acid PET tracer for multiple myeloma |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2019/03/18 19:29:25 |
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Basic information
Public title
Molecular Imaging using amino-acid PET tracer: Clinical research for diagnostic and therapeutic evaluation with amino acid PET tracer for multiple myeloma
Acronym
Molecular Imaging using amino-acid PET tracer: Clinical research for diagnostic and therapeutic evaluation with amino acid PET tracer for multiple myeloma
Scientific Title
Molecular Imaging using amino-acid PET tracer: Clinical research for diagnostic and therapeutic evaluation with amino acid PET tracer for multiple myeloma
Scientific Title:Acronym
Molecular Imaging using amino-acid PET tracer: Clinical research for diagnostic and therapeutic evaluation with amino acid PET tracer for multiple myeloma
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of Methionin PET/CT for treatment plannning and therapeutic assessment of multiple myeloma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To explore how Methionin PET/CT can contribute to initial diagnosis, treatment plannning and therapeutic effect of multiple myeloma.
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
| Other |
Interventions/Control_1
The patients with multiple myeloma undergo Methionine PET/CT, and compare the result with current diagnostic criteria including FDG-PET/CT.In this process, histopathological findings, clinical findings and other imaging modality will be refered.
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) adult
2) Patient with pathologically diagnosed as multiple myeloma
3) Completed the written informed consent.
Key exclusion criteria
1)Patient in emargency state
2)Uncontorolable diabetics
3)Patient with severe comorbid disease includng liver dysfunction, renel failure or metabolic damage.
4)Patient with psychiatric disease
5)pregnant female, possible pregnant female, breast-feeding woman
6) allergy for Methionine
7) Those who are determined as not appropriate for the study by the principle investigator.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryogo Minamimoto |
Organization
Nathional Center for Global Health and Medicine
Division name
Division of Nuclear Medicine
Zip code
Address
1-21-1, Toyama,Shijyuku-ku, Tokyo
TEL
03-3202-7181
rminamimoto@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryogo Minamimoto |
Organization
Nathional Center for Global Health and Medicine
Division name
Division of Nuclear Medicine
Zip code
Address
1-21-1, Toyama,Shijyuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
rminamimoto@hosp.ncgm.go.jp
Sponsor or person
Institute
Nathional Center for Global Health and Medicine. Division of Nuclear Medicine
Institute
Department
Personal name
Funding Source
Organization
Nathional Center for Global Health and Medicine hospital.
Organization
Division
Category of Funding Organization
Government offices of other countries
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
| 2016 | Year | 10 | 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 | 05 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2016 | Year | 09 | Month | 15 | Day |
Last modified on
| 2019 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027718
