UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025171 |
|---|---|
| Receipt number | R000028958 |
| Scientific Title | Evaluation of Osteonecrosis of the Jaw by using NaF-Positron Emission Tomography / Computerized Tomography |
| Date of disclosure of the study information | 2016/12/07 |
| Last modified on | 2020/06/21 01:16:19 |
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Basic information
Public title
Evaluation of Osteonecrosis of the Jaw by using NaF-Positron Emission Tomography / Computerized Tomography
Acronym
Evaluation of Osteonecoris of the Jaw by using NaF-PET
Scientific Title
Evaluation of Osteonecrosis of the Jaw by using NaF-Positron Emission Tomography / Computerized Tomography
Scientific Title:Acronym
Evaluation of Osteonecoris of the Jaw by using NaF-PET
Region
| Japan |
Condition
Condition
Osteonecrosis of the Jaw
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the sensitivity of dynamic 18F-sodium fluoride Positron Emission Tomography/Computerized Tomography (NaF-PET/CT) scanning in the diagnosis of Osteonecrosis in the Jaw, and to test their suitability for assessing the severity of Osteonecrosis in the jaw.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Region of Interests (ROIs) are defined in both affected side and unaffected side. The time-activity curves (TACs) and the standardized uptake values (SUVs) for each ROI are analyzed to investigate bone blood flow and bone metabolism.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
NaF-PET/CT scanning for all subjects
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
Patient with Osteonecrosis of the Jaw because of medication or radiotherapy
Key exclusion criteria
1.Women who are or may be pregnant, within 28 days after childbirth, or in nursing mothers
2.Having difficulty attending the test due to psychological disorder
3.Having difficulty attending the test due to psychological disorder insufficient ability to judge
4.Patient with osteonecrosis of the jaw because of strontium 89 therapy
5.Patient who are judged as inappropriate for the test by doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hanako Suenaga |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Advanced Prosthetic Dentistry
Zip code
Address
4-1, Seiryo-machi, Aobaku, Sendai-city, Miyagi JAPAN
TEL
+81-22-717-8369
suenaga-thk@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hanako Suenaga |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Advanced Prosthetic Dentistry
Zip code
Address
4-1, Seiryo-machi, Aobaku, Sendai-city, Miyagi JAPAN
TEL
022-717-8369
Homepage URL
suenaga-thk@umin.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
Nil
Publication of results
Unpublished
Result
URL related to results and publications
Nil
Number of participants that the trial has enrolled
0
Results
Nil
Results date posted
| 2020 | Year | 06 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Nil
Participant flow
Nil
Adverse events
Nil
Outcome measures
Nil
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 07 | Day |
Last modified on
| 2020 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028958
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
