UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005866 |
|---|---|
| Receipt number | R000006897 |
| Scientific Title | Evaluation of 18F-FDG-PET/CT in the diagnosis and treatment response of bone metastasis. |
| Date of disclosure of the study information | 2011/06/28 |
| Last modified on | 2019/10/08 13:01:09 |
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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
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
Sponsor or person
Institute
National Cancer Center Research Projects
Management expenses Grants from the Government to National Cancer Research Center
Institute
Department
Personal name
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
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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006897
