Oral Stent Device for Radiation Treatments of Oral Cancers

Indiana University

Status: Withdrawn

Conditions: Tongue Tumor; Tongue Cancer

Treatments: Device: Experimental Oral Stent Device; Diagnostic Test: CT Scan

Study type: Observational

Funder types: Other

Identifiers

NCT04041141

IUSCC-0687

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Oral Cancer

Description:

Patients receiving curative radiation treatment for an oral cancer.

Treatment:

Diagnostic Test: CT Scan

Device: Experimental Oral Stent Device