UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024075 |
|---|---|
| Receipt number | 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 07:53:38 |
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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
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
hnddrnm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027717
