UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018176 |
|---|---|
| Receipt number | 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 | 2024/01/08 13:43:58 |
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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
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
katokt@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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 | 02 | Month | 28 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2025 | Year | 02 | Month | 28 | 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
| 2024 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020964
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
