Exploratory study on negative air pressure oral stents and oral markers aimed at curative external radiation therapy for tongue cancer patients

JRCT ID: jRCTs032240314

Registered date:02/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: tongue cancer
• Date of first enrollment: 02/09/2024
• Target sample size: 7
• Study type: Interventional
• Intervention(s): Placement of intraoral markers, spacer installation, and contrast-enhanced MRI imaging.

Outcome(s)

• Primary Outcome: Marker visibility, spacer's tongue fixation performance.
• Secondary Outcome: Marker adhesion and shape retention properties, suction pressure used for fixation, tolerability, incidence of adverse events, clarity of tumor margins.

Key inclusion & exclusion criteria

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

Include criteria

1. Individuals who have provided written consent to participate in this clinical study.
2. Individuals diagnosed with tongue cancer with a tumor T-factor of T3 or less (limited to untreated individuals).
3. Individuals scheduled for contrast-enhanced MRI examination as part of standard insurance-covered medical care.
4. Individuals aged 18 to 80 years at the time of consent acquisition.

Exclude criteria

1. Individuals with apparent abnormalities in the oral cavity and temporomandibular joint (such as stomatitis, tooth mobility, temporomandibular joint disorder, uncontrolled pain, etc.).
2. Individuals with difficulty breathing through the nose while the mouth is closed (such as nasal congestion, Eustachian tube obstruction, etc.).
3. Individuals with claustrophobia or fear of dark places.
4. Individuals with symptoms of involuntary movements such as tremors.
5. Individuals with severe comorbidities or a history of serious illnesses.
6. Individuals with impaired renal function (GFR 30 or below).
7. Individuals with a history of severe hypersensitivity to components such as resin, acrylic ester, olive oil, blue dye, Aron Alpha A, or contrast agents (Magnascope).
8. Pregnant women or those who might be pregnant.
9. Other individuals deemed inappropriate for participation in this study by the principal investigator (such as those with cognitive impairment or involuntary movements like tremors).

Related Information

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