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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032240314
Enrollment
7
Registered
2024-09-02
Start date
2025-02-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tongue cancer

Interventions

Placement of intraoral markers, spacer installation, and contrast-enhanced MRI imaging.

Sponsors

Takuya Nagano
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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 aged 18 or older years at the time of consent acquisition.

Exclusion criteria

Exclusion 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, contrast agents (Magnascope), or Cotton-like wound dressing and protective material(Ora-Aid). 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).

Design outcomes

Primary

MeasureTime frame
Marker visibility, spacer's tongue fixation performance.

Secondary

MeasureTime frame
Marker adhesion and shape retention properties, suction pressure used for fixation, tolerability, incidence of adverse events, clarity of tumor margins.

Contacts

Public ContactHaraguchi Mihoko

Institute of Science Tokyo Hospital

spaceoral@ml.tmd.ac.jp+81-3-5803-5720

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026