Oral Stent Device for Radiation Treatments of Oral Cancers

Withdrawn before enrolling

Conditions studied: Tongue Tumor, Tongue Cancer

In brief

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.

Key facts

Study ID

NCT04041141

Run by

Indiana University

People needed

0

Starts

2019-09-25

Expected to finish

2021-02-03

Last updated by the study team

2021-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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)

You may not qualify if…

• History of bleeding disorder
• History of allergy to dental grade material

Where it is running

• Indiana University Melvin & Bren Simon Cancer Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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