UMIN-CTR Clinical Trial

Basic information
Public title	Research on motion management and tongue compression by new developed mouthpiece for radiotherapy
Acronym	Research on the usefulness of a new mouthpiece for radiotherapy
Scientific Title	Research on motion management and tongue compression by new developed mouthpiece for radiotherapy
Scientific Title:Acronym	Research on the usefulness of a new mouthpiece for radiotherapy
Region	Japan

Condition
Condition	Cartinoma of maxillary sinus
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the usefulness of a radiotherapy bite block for motion suppression and tongue depression
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The amount of positional displacement caused by body movement during fixation by the head and neck shell is measured with a cine MRI image.
Key secondary outcomes	Tongue compression function with mouthpiece

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Cine MRI imaging is performed by fixing with a head and neck shell and wearing a mouthpiece
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adult
Key exclusion criteria	When MRI is contraindicated, the subject has dentures or moving teeth, or the subject is claustrophobic
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Katsumasa Middle name Last name Nakamura
Organization	Hamamatsu University Scholl of Medicine
Division name	Department of Radiation Oncology
Zip code	431-3192
Address	Handayama 1-20-1, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL	053-435-2242
Email	nakam@hama-med.ac.jp

Public contact
Name of contact person	1st name Masataka Middle name Last name Sakamoto
Organization	Hamamatsu University School of Medicine
Division name	Cooperative Major in Medical Photonics
Zip code	431-3192
Address	Handayama 1-20-1, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL	053-435-2784
Homepage URL
Email	skmt@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine
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	Hamamatsu University School of Medicine
Address	Handayama 1-20-1, Higashi-ku, Hamamatsu, Shizuoka, Japan
Tel	053-435-2680
Email	rinri@hama-med.ac.jp

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	2021 Year 02 Month 01 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	2020 Year 09 Month 01 Day
Date of IRB	2020 Year 10 Month 12 Day
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 05 Day
Last modified on	2021 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048972