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


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 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


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


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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name