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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018176
Receipt No. R000020964
Scientific Title Clinical studies on analysis of bone diseases with 18F-Na PET/CT
Date of disclosure of the study information 2015/07/10
Last modified on 2020/01/06

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Basic information
Public title Clinical studies on analysis of bone diseases with 18F-Na PET/CT
Acronym Clinical studies on analysis of bone diseases with 18F-Na PET/CT
Scientific Title Clinical studies on analysis of bone diseases with 18F-Na PET/CT
Scientific Title:Acronym Clinical studies on analysis of bone diseases with 18F-Na PET/CT
Region
Japan

Condition
Condition Bone metastases
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacies of 18F-fluoride PET/CT, 18F-FDG PET/CT, and 99mTc bone scintigraphy (planar and SPECT) for the analysis of bone metastases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 18F-Na PET/CT
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 18F-Na PET/CT
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
90 years-old >
Gender Male and Female
Key inclusion criteria Bone metastases
Key exclusion criteria A person under age
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Katsuhiko
Middle name
Last name Kato
Organization Nagoya University Graduate School of Medicine
Division name Department of Radiological and Medical Laboratory Sciences
Zip code 461-8673
Address 1-20, Daikominami 1-chome, Higashi-ku, Nagoya
TEL 052-719-1590
Email katokt@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Katsuhiko
Middle name
Last name Kato
Organization Nagoya University Graduate School of Medicine
Division name Department of Radiological and Medical Laboratory Sciences
Zip code 461-8673
Address 1-20, Daikominami 1-chome, Higashi-ku, Nagoya
TEL 052-719-1590
Homepage URL
Email katokt@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya University Graduate School of Medicine
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel 052-744-2327
Email katokt@med.nagoya-u.ac.jp

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
2015 Year 07 Month 10 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 Enrolling by invitation
Date of protocol fixation
2015 Year 07 Month 04 Day
Date of IRB
2019 Year 06 Month 24 Day
Anticipated trial start date
2015 Year 07 Month 04 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
2025 Year 03 Month 31 Day
Date trial data considered complete
2025 Year 03 Month 31 Day
Date analysis concluded
2025 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 03 Day
Last modified on
2020 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020964

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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