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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018793
Receipt No. 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

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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
Email 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
Email chikui@rad.dent.kyushu-u.ac.jp

Sponsor
Institute Kyushu University, Faculty of dental science.
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017675

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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