UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018793 |
|---|---|
| Receipt number | R000017675 |
| Scientific Title | Amide proton transfer imaging of the lesions in the orofacial region |
| Date of disclosure of the study information | 2015/08/25 |
| Last modified on | 2016/03/04 17:17:34 |
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Basic information
Public title
Amide proton transfer imaging of the lesions in the orofacial region
Acronym
APT imaging of the lesions in the orofacial region
Scientific Title
Amide proton transfer imaging of the lesions in the orofacial region
Scientific Title:Acronym
APT imaging of the lesions in the orofacial region
Region
| Japan |
Condition
Condition
Tumorous lesions in the orofacial regions
Classification by specialty
| Radiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy of the amide proton transfer imaging (APT imaging) for the imaging diagnosis of the lesion in the orofacial region.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation between the parameters obtained by APT imagines and the histological diagnosis,
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
In the clinical MR examination, the additional MR sequence (APT imaging) is added.
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
The patient with suspect of the head and neck tumor who is planned to undergo MR study. The diameter of the mass is over 2 cm.
Key exclusion criteria
The patient with the contradiction to MR exam.
The patient wears the metallic dental prosthesis in the whole dental arch.
The patient cannot keep spine position for thirty minutes.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Yoshiura |
Organization
Kyushu University, Faculty of dental science.
Division name
Department of Oral and Maxillofacial radiology
Zip code
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka
TEL
0926426407
yoshiura@rad.dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Chikui |
Organization
Kyushu University, Faculty of dental science.
Division name
Department of Oral and Maxillofacial radiology
Zip code
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka
TEL
0926426407
Homepage URL
chikui@rad.dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University, Faculty of dental science.
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 08 | Month | 25 | 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
We assessed the usefulness of Amide proton transfer (APT) imaging in differential diagnosis of the head and neck region (n=45). APT ratio (APTR) was defined as magnetization transfer asymmetry at 3.5ppm. The sarcoma had the highest mean APTRs, followed by those of malignant salivary carcinoma and squamous cell carcinoma, however, the significant differences were found among theses malignant lesions. The mean APTRs of the cysts had wide variety depend on the contend fluid. The benign tumor had also wide variety. Therefore, at present, the APT imaging is considered to be not useful for the differential diagnosis in the head and neck region.
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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2016 | Year | 03 | 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
| 2015 | Year | 08 | Month | 25 | Day |
Last modified on
| 2016 | 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=R000017675
