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Recruitment status Terminated
Unique ID issued by UMIN UMIN000027684
Receipt No. 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

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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
Last 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
Email asahimachinm@gmail.com

Public contact
1st 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
Email asahimachinm@gmail.com

Sponsor
Institute Department of Nuclear medicine, Osaka City University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031709

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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