NCT04041141

Oral Stent Device for Radiation Treatments of Oral Cancers

A Pilot Study Assessing an Oral Stent Device for Radiation Treatments of Oral Cancers

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Tongue Tumor
• Tongue Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CT Scan	An additional cone beam CT will be repeated at midcourse of therapy (3rd week) and during the end of therapy (5th week)
DEVICE	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

Timeline

• Start date: 2019-09-25
• Primary completion: 2021-02-03
• Completion: 2021-02-03
• First posted: 2019-08-01
• Last updated: 2021-02-09

Locations

1 site across 1 country: United States