Oral Stent Device for Radiation Treatments of Oral Cancers

Indiana University

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Tongue Tumor Tongue Cancer

Interventions

CT ScanDIAGNOSTIC_TEST

An additional cone beam CT will be repeated at midcourse of therapy (3rd week) and during the end of therapy (5th week)

Experimental Oral Stent DeviceDEVICE

Patients undergoing standard of care planning for head and neck tongue cancer will have a radiation plan of the body imaged via CT scan construction with the experimental oral stent device in place

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

The volume of mandible irradiated to >55 Gy

Time frame: volume irradiated at Day 0

Secondary Outcomes

The position of the fiducial marker

Fiducial coordinate measured (mm) on XYZ on planning CT

Time frame: Change in position at Day 0, Week 3, Week 5

Data from ClinicalTrials.gov

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