NCT04041141
Withdrawn
Not Applicable
A Pilot Study Assessing an Oral Stent Device for Radiation Treatments of Oral Cancers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tongue Tumor
- Sponsor
- Indiana University
- Locations
- 1
- Primary Endpoint
- The volume of mandible irradiated to >55 Gy
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Mark Langer
Professor of Clinical Radiation Oncology
Indiana University
Eligibility Criteria
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
Outcomes
Primary Outcomes
The volume of mandible irradiated to >55 Gy
Time Frame: volume irradiated at Day 0
Secondary Outcomes
- The position of the fiducial marker(Change in position at Day 0, Week 3, Week 5)
Study Sites (1)
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