UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of 18F-FDG-PET/CT in the diagnosis and treatment response of bone metastasis.
Acronym	18F-FDG-PET/CT in bone metastasis.
Scientific Title	Evaluation of 18F-FDG-PET/CT in the diagnosis and treatment response of bone metastasis.
Scientific Title:Acronym	18F-FDG-PET/CT in bone metastasis.
Region	Japan

Condition
Condition	bone metastasis
Classification by specialty	Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We evaluate the utility of PET/CT in the diagnosis and monitoring of treatment response, and establish a brand-new system for the clinical management of bone metastasis, which include PET/CT.
Basic objectives2	Others
Basic objectives -Others	Early diagnosis and treatment
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Diagnostic rate of PET/CT for bone metastasis is compared with that of bone scintigraphy. The utility of PET/CT in determining the treatment response of bone metastasis is evaluated.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with bone metastasis
Key exclusion criteria	None
Target sample size	220

Research contact person
Name of lead principal investigator	1st name Middle name Last name Haruo Iguchi
Organization	National Hospital Organization Shikoku Cancer Center
Division name	Clinical Research Center
Zip code
Address	Minamiumemotomachi Ko 160, Matsuyama, Ehime
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Shikoku Cancer Center
Division name	Clinical Research Center
Zip code
Address	Minamiumemotomachi Ko 160, Matsuyama, Ehime
TEL
Homepage URL
Email

Sponsor
Institute	National Cancer Center Research Projects Management expenses Grants from the Government to National Cancer Research Center
Institute
Department

Funding Source
Organization	Research Grant on Cancer Research (Grants No. 22-54) from the Government to National Cancer Research Center
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Shikoku Cancer Center, Yokohama City University, Shizuoka Cancer Center, Kanazawa University Hospital, National Cancer Center Hospital, Cancer Institute Hospital
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	四国がんセンター（愛媛県）、横浜市立大学（神奈川県）、静岡県立静岡がんセンター（静岡県）、金沢大学医学部附属病院（神奈川県）、国立がん研究センター（東京都）、がん研有明病院（東京都）

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 28 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
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 15 Day
Date of IRB	2011 Year 06 Month 21 Day
Anticipated trial start date	2011 Year 06 Month 28 Day
Last follow-up date	2014 Year 01 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Treatment responce is assessed every 3 to 6 months using PET/CT, bone scintigraphy, serum levels of bone metabolic markers and tumor markers, and presence or absence of skeletal-related events.

Management information
Registered date	2011 Year 06 Month 28 Day
Last modified on	2019 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006897