UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026275
Receipt No. R000030040
Scientific Title Usefulness of 18F-NaF PET/CT for bone metastasis
Date of disclosure of the study information 2017/02/28
Last modified on 2020/03/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Usefulness of 18F-NaF PET/CT for bone metastasis
Acronym 18F-NaF for bone metastasis
Scientific Title Usefulness of 18F-NaF PET/CT for bone metastasis
Scientific Title:Acronym 18F-NaF for bone metastasis
Region
Japan

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

Objectives
Narrative objectives1 To compare diagnostic efficiency and prediction of treatment for bone metastasis between 18F-NaF PET and conventional images includes bone scintigraphy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effectiveness of 18F-NaF PET for determining of predicting the effect of bone metastasis treatment.
Key secondary outcomes Effectiveness of 18F-NaF PET for detecting bone metastasis.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Injection of PET tracer
One injection for one exam
Radiation dose is under 370 MBq for one exam
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 1) Diagnosed as bone metastasis
2) Regardless of sex
3) informed consent is available
Key exclusion criteria 1) Who have already undergone radiotherapy or surgical treatment for bone metastasis
2) Poor condition (i.e. Performance status 3 or 4)
3) Those who is breastfeeding, pregnant or wish for pregnancy
4) Those who is thought to be inappropriate by researcher
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Akihiro
Middle name
Last name Nishie
Organization Graduate School of Medical Science, Kyushu University
Division name Department of Clinical Radiology
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuka-shi, Fukuoka, Japan
TEL 092-641-1151
Email anishie@radiol.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Yoshiyuki
Middle name
Last name Kitamura
Organization Graduate School of Medical Science, Kyushu University
Division name Department of Clinical Radiology
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuka-shi, Fukuoka, Japan
TEL 092-641-1151
Homepage URL
Email ykita@radiol.med.kyushu-u.ac.jp

Sponsor
Institute Department of Clinical Radiology, Graduate School of Medical Science, Kyushu University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyushu University research ethics committee
Address 3-1-1 Maidashi, Higashi-ku, Fukuka-shi, Fukuoka, Japan
Tel 092-642-5082
Email byskenkyu@jimu.kyushu-u.ac.jp

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 02 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 8
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 No longer recruiting
Date of protocol fixation
2017 Year 02 Month 02 Day
Date of IRB
2017 Year 02 Month 02 Day
Anticipated trial start date
2017 Year 02 Month 28 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information under progress

Management information
Registered date
2017 Year 02 Month 23 Day
Last modified on
2020 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030040

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.