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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024075
Receipt No. R000027717
Scientific Title Optimized Magnetic Resonance Imaging in patients with tongue cancers
Date of disclosure of the study information 2016/12/20
Last modified on 2018/10/15

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Basic information
Public title Optimized Magnetic Resonance Imaging in patients with tongue cancers
Acronym Optimized Magnetic Resonance Imaging in patients with tongue cancers
Scientific Title Optimized Magnetic Resonance Imaging in patients with tongue cancers
Scientific Title:Acronym Optimized Magnetic Resonance Imaging in patients with tongue cancers
Region
Japan

Condition
Condition Tongue cancer and normal subjects
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To optimize magnetic resonance imaging techniques and sequences in patients with tongue cancers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Making assist device for MR imaging and assessement of its usefulness.
2)Comparison between images by using different type of MRI coil.
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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 MRI with or without assist device
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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients with tongue cancer who receive brachytherapy.
Normal subjects who have no history of malignancy.
The patients and normal subjects that a written consent was obtained.
Key exclusion criteria Contraindication to MRI.
Patient with no informed consent.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ukihide Tateishi
Organization Tokyo Medical and Dental University
Division name Department of Diagnostic radiology
Zip code
Address 1-5-45, Yushima, Bunkyoku, Tokyo, 113-0034
TEL 03-5803-5311
Email ttisdrnm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makiko Honda
Organization Tokyo Medical and Dental University
Division name Department of Diagnostic radiology
Zip code
Address 1-5-45, Yushima, Bunkyoku, Tokyo, 113-0034
TEL 03-5803-5311
Homepage URL
Email hnddrnm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Hitachi
Organization
Division
Category of Funding Organization Profit 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
2016 Year 12 Month 20 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
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
2016 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 15 Day
Last modified on
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027717

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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