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Development of spacers and markers for radiotherapy of tongue cancer.

Exploratory study of negative pressure aspirated tongue-fixing spacers and intraoral fiducial markers for radical external radiation therapy of tongue cancer.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032230225
Enrollment
5
Registered
2023-07-13
Start date
2023-09-04
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

healthy volunteer

Interventions

Attachment of fiducial markers, installation of oral spacers, and conducting X-ray radiation imaging.

Sponsors

Nagano Takuya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
The visibility of the fiducial markers and the performance of the oral spacers in tongue stabilization.

Secondary

MeasureTime frame
The adhesiveness and shape maintenance of the fiducial markers, evaluation of suction pressure during fixation, the tolerability of oral spacers, and adverse events.

Contacts

Public ContactMihoko Haraguchi

Tokyo Medical and Dental University Hospital

pararotti.mfp@tmd.ac.jp+81-3-5803-5720

Outcome results

None listed

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