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replaced with other study
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Cancer | Patients receiving curative radiation treatment for an oral cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT Scan | Diagnostic Test | An additional cone beam CT will be repeated at midcourse of therapy (3rd week) and during the end of therapy (5th week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The volume of mandible irradiated to >55 Gy | volume irradiated at Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| The position of the fiducial marker | Fiducial coordinate measured (mm) on XYZ on planning CT | Change in position at Day 0, Week 3, Week 5 |
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Inclusion Criteria:
Exclusion Criteria:
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Potential patients will be identified in the Oncology outpatient clinics or by referrals from outside physicians at the Indiana University Simon Cancer Center.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Langer, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin & Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D014062 | Tongue Neoplasms |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Experimental Oral Stent Device | 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 |
|
| D009057 |
| Stomatognathic Diseases |
| D014060 | Tongue Diseases |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |