UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026275 |
|---|---|
| Receipt number | 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 | 2025/03/04 08:46:42 |
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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
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
ykita@radiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Clinical Radiology, Graduate School of Medical Science, Kyushu University
Institute
Department
Personal name
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
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
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
8
Results
SUVmax of the NaF PET may predict efficacy of the 223RaCl2 therapy in the mCRPC.
Results date posted
| 2025 | Year | 03 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eight patients with mCRPC who underwent NaF-PET from Mar 2017 to Aug 2018 were included (Table1). All patients were measured ALP, PSA within a week of NaF-PET examination (ALPpre, PSApre). Seven of the 8 patients underwent 223RaCl2 therapy. All patients measured serum markers (ALPpost, PSApost) after the therapy excluded one (patient no.7).
Participant flow
Eight patients with mCRPC who underwent NaF-PET from Mar 2017 to Aug 2018 were included (Table1). All patients were measured ALP, PSA within a week of NaF-PET examination (ALPpre, PSApre). Seven of the 8 patients underwent 223RaCl2 therapy. All patients measured serum markers (ALPpost, PSApost) after the therapy excluded one (patient no.7).
Adverse events
None
Outcome measures
Correlation between the semi-quantitative value and serum markers
Correlation between the semi-quantitative value and reduction rate of the serum markers
Semi-quantitative value: SUVmax, MTV and TLG, Serum markers: ALP and PSA
Correlation coefficient was calculated for statistic analysis.
P value <0.05 was considered as statistically significant.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
Management information
Registered date
| 2017 | Year | 02 | Month | 23 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030040
