UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of treatment monitoring by quantitative index in bone scintigraphy of patients with bone metastasis
Acronym	Evaluation of treatment monitoring by quantitative index in bone scintigraphy of patients with bone metastasis
Scientific Title	Evaluation of treatment monitoring by quantitative index in bone scintigraphy of patients with bone metastasis
Scientific Title:Acronym	Evaluation of treatment monitoring by quantitative index in bone scintigraphy of patients with bone metastasis
Region	Japan

Condition
Condition	Patients with bone metastasis
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of treatment monitoring
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Usefulness of evaluation of treatment monitoring
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult patients with bone metastasis indicating manifestation of intention, agreeing to research
Key exclusion criteria	Patients with injection leakage of drug, body movement during imaging, or poor image quality
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hidekazu Tanaka
Organization	Gifu University Graduate School of Medicine
Division name	Department of Radiology
Zip code
Address	Yanagido 1-1, Gifu City
TEL	058-230-6437
Email	htanaka-gif@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hidekazu Tanaka
Organization	Gifu University Graduate School of Medicine
Division name	Department of Radiology
Zip code
Address	Yanagido 1-1, Gifu City
TEL	058-230-6437
Homepage URL
Email	htanaka-gif@umin.ac.jp

Sponsor
Institute	Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Self funding
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 04 Month 13 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	Completed
Date of protocol fixation	2016 Year 11 Month 10 Day
Date of IRB	2017 Year 01 Month 04 Day
Anticipated trial start date	2017 Year 01 Month 04 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	N.A.

Management information
Registered date	2017 Year 04 Month 12 Day
Last modified on	2019 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030928