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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024788
Receipt No. R000028503
Scientific Title Study for early PET/MR imaging after intravenous administration of FDG in malignant and inflammatory diseases
Date of disclosure of the study information 2016/11/14
Last modified on 2016/11/10

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Basic information
Public title Study for early PET/MR imaging after intravenous administration of FDG in malignant and inflammatory diseases
Acronym Kyushu University PET/MR imaging
Scientific Title Study for early PET/MR imaging after intravenous administration of FDG in malignant and inflammatory diseases
Scientific Title:Acronym Kyushu University PET/MR imaging
Region
Japan

Condition
Condition Malignant and inflammatory diseases
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the usefulness of early FDG-PET/MR imaging in the detection, characterization, tumor staging and determination of treatment response of malignant lesions and in the differentiation of malignant from inflammatory lesions, and also to compare diagnostic performance of FDG-PET/MR imaging with that of other imaging modalities such as CT, MRI and FDG-PET/CT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Diagnostic performance including the detection, characterization, tumor staging, determination of treatment response of malignant lesions, and the differentiation of malignant from inflammatory lesions
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 PET/MRI
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 Malignant and/or inflammatory disease in head/neck, chest, abdomen/pelvis, and muscloskeltal regions
Key exclusion criteria Contraindication of MRI
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Watanabe
Organization Kyushu University Graduate School of Medical Sciences
Division name Molecular Imaging and Diagnosis
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 0926425695
Email yw140557@radiol.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryotaro Kamei
Organization Kyushu University Graduate School of Medical Sciences
Division name Clinical Radiology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 0926425695
Homepage URL
Email rkamei@radiol.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Kyushu University Graduate School of Medical Sciences
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
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 11 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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 11 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

Management information
Registered date
2016 Year 11 Month 10 Day
Last modified on
2016 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028503

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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