Development of spacers and markers for radiotherapy of tongue cancer.

JRCT ID: jRCTs032230225

Registered date:13/07/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: healthy volunteer
• Date of first enrollment: 13/07/2023
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Attachment of fiducial markers, installation of oral spacers, and conducting X-ray radiation imaging.

Outcome(s)

• Primary Outcome: The visibility of the fiducial markers and the performance of the oral spacers in tongue stabilization.
• Secondary Outcome: The adhesiveness and shape maintenance of the fiducial markers, evaluation of suction pressure during fixation, the tolerability of oral spacers, and adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Individuals who have given their written consent to participate in this clinical study.
2. Individuals who are between the ages of 18 and 80 at the time of consent acquisition.

Exclude criteria

1. Individuals with apparent abnormalities in the oral cavity and temporomandibular joint (e.g., stomatitis, loose teeth, temporomandibular joint disorder).
2. Individuals who have difficulty breathing through the nose when the mouth is closed (e.g., nasal congestion, eustachian tube blockage).
3. Individuals with a phobia of confined or dark places.
4. Individuals with serious concurrent diseases or a history of such diseases.
5. Individuals with a history of severe allergic reactions to ingredients such as resin, barium sulfate, or alunite.
6. Pregnant individuals or those who may be pregnant.
7. Individuals who the principal investigator of the study has determined are inappropriate for participation in this research.

Related Information

• Primary Sponsor: Nagano Takuya
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Japan Society for the Promotion of Science