UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027684 |
|---|---|
| Receipt number | R000031709 |
| Scientific Title | Prospective non-blinded examination by comparing bone PET with F-18 NaF and conventional bone scintigraphy |
| Date of disclosure of the study information | 2017/06/08 |
| Last modified on | 2018/10/11 16:01:04 |
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Basic information
Public title
Prospective non-blinded examination by comparing bone PET with F-18 NaF and conventional bone scintigraphy
Acronym
Prospective non-blinded examination by comparing bone PET with F-18 NaF and conventional bone scintigraphy
Scientific Title
Prospective non-blinded examination by comparing bone PET with F-18 NaF and conventional bone scintigraphy
Scientific Title:Acronym
Prospective non-blinded examination by comparing bone PET with F-18 NaF and conventional bone scintigraphy
Region
| Japan |
Condition
Condition
bone disease
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Endocrinology and Metabolism | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Endocrine surgery | Oto-rhino-laryngology |
| Orthopedics | Urology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the usefulness of bone PET by comparing bone PET with bone scintigraphy (including SPECT / CT) with F-18 NaF for patients scheduled to perform bone scintigraphy in bone diseases .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate the usefulness of the quantitative diagnostic ability of bone PET by comparing the quantitative evaluation of lesions in bone PET and bone scintigraphy performed almost at the same time.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Between the approval of the Ethics Committee of Osaka City University Medical School Hospital and March 31, 2019, 40 patients with bone disease who underwent bone scintigraphy receive 185 MBq of F-18 NaF.
Interventions/Control_2
Tc-99m HMDP 740 MBq is administered to 40 bone disease patients who undergo bone scintigraphy from approval of Osaka City University Medical School Hospital Ethics Committee until March 31, 2019.
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
Patients planning to perform bone scintigraphy in bone disease
Key exclusion criteria
1) Patients with a history of allergy to the study drug
2) During pregnancy or suspected women, lactating women
3) Patients who received other test drugs or test drugs within 3 months prior to the start of administration of study drug
4) Patients judged by the investigator as inappropriate as subjects
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Joji Kawabe, M.D.,Ph.D. |
Organization
Osaka City university Hospital
Division name
Department of Nuclear medicine
Zip code
Address
1-5-7, Asahimachi, Abenoku, Osaka City, JAPAN
TEL
06-6645-2256
asahimachinm@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Joji Kawabe, M.D.,Ph.D. |
Organization
Graduate school of medicine, Osaka city university
Division name
Department of Nuclear medicine
Zip code
Address
1-4-3, Asahimachi, Abenoku, Osaka City, JAPAN
TEL
06-6645-3885
Homepage URL
asahimachinm@gmail.com
Sponsor or person
Institute
Department of Nuclear medicine, Osaka City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Nuclear medicine, Osaka City University Hospital
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
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
| 2017 | Year | 06 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | 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
| 2017 | Year | 06 | Month | 08 | Day |
Last modified on
| 2018 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031709
