Oral Stent Device for Radiation Treatments of Oral Cancers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-25

Study Completion Date

2021-02-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Tongue Tumor Tongue Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oral Cancer

Patients receiving curative radiation treatment for an oral cancer.

CT Scan

Intervention Type DIAGNOSTIC_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 Device

Intervention Type DEVICE

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

Interventions

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CT Scan

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

Intervention Type DIAGNOSTIC_TEST

Experimental Oral Stent Device

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

Intervention Type DEVICE

Eligibility Criteria

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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)