UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective non-blinded examination by comparing bone PET with F-18 NaF and conventional bone scintigraphy
Title of the study (Brief title)	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	Joji Kawabe, M.D.,Ph.D.
Organization	Osaka City university Hospital
Division name	Department of Nuclear medicine
Address	1-5-7, Asahimachi, Abenoku, Osaka City, JAPAN
TEL	06-6645-2256
Email	asahimachinm@gmail.com

Public contact
Name of contact person	Joji Kawabe, M.D.,Ph.D.
Organization	Graduate school of medicine, Osaka city university
Division name	Department of Nuclear medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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