UMIN-CTR Clinical Trial

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
Last 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
Email	rminamimoto@hosp.ncgm.go.jp

Public contact
1st 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
Email	rminamimoto@hosp.ncgm.go.jp

Sponsor
Institute	Nathional Center for Global Health and Medicine. Division of Nuclear Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027718