Clinical trial · Observational
Oral Stent Device for Radiation Treatments of Oral Cancers
A Pilot Study Assessing an Oral Stent Device for Radiation Treatments of Oral Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): replaced with other study
Summary
Brief summary (as posted)
The purpose of this study is to examine that ability of the experimental oral stent device to reduce the volume of mandible receiving \>55 Gy by 50%during radiation treatment as assessed duri radiation treatment planning. Patients will have CT scans at three time-points during their standard of care radiation treatment. During these visits patients will receive scans via CT or cone beam CT scan, with both the standard and experimental oral stent devices. During radiation treatment patients will receive the standard oral stent device.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tongue Cancer | Malignant Tongue Neoplasm | CURATED_BROADER | 0.80 |
| Tongue Tumor | Tongue Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT Scan | Diagnostic Test | — | UNRESOLVED |
| Experimental Oral Stent Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Oral Cancer
- description
- Patients receiving curative radiation treatment for an oral cancer.
- interventionNames
- Diagnostic Test: CT Scan
- Device: Experimental Oral Stent Device
Primary outcomes (1)
- measure
- The volume of mandible irradiated to >55 Gy
- timeFrame
- volume irradiated at Day 0
Secondary outcomes (1)
- measure
- The position of the fiducial marker
- timeFrame
- Change in position at Day 0, Week 3, Week 5
- description
- Fiducial coordinate measured (mm) on XYZ on planning CT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 year old at the time of informed consent * Ability to provide written informed consent and HIPAA authorization * Accepted for curative radiation treatment of a tongue tumor, either intact or postoperatively * Signed consent to study participation * No history of bleeding disorder * Platelets within normal limits (150-450 k/cumm) Exclusion Criteria: * History of bleeding disorder * History of allergy to dental grade material
References
Publications (0)
Data not yet available