Oral Stent Device for Radiation Treatments of Oral Cancers

Withdrawn

• Conditions: Tongue Tumor; Tongue Cancer
• Interventions: Diagnostic Test: CT Scan; Device: Experimental Oral Stent Device

• Registration Number: NCT04041141
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-30
• Study First Posted: 2019-08-01
• Study Start: 2019-09-25
• Status Verified: 2021-02
• Primary Completion: 2021-02-03
• Study Completion: 2021-02-03
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral Cancer	Experimental Oral Stent Device	Patients receiving curative radiation treatment for an oral cancer.
Oral Cancer	CT Scan	Patients receiving curative radiation treatment for an oral cancer.

Primary Outcome Measures

Name	Time	Method
The volume of mandible irradiated to >55 Gy	volume irradiated at Day 0

Secondary Outcome Measures

Name	Time	Method
The position of the fiducial marker	Change in position at Day 0, Week 3, Week 5	Fiducial coordinate measured (mm) on XYZ on planning CT

Trial Locations

Locations (1)

Indiana University Melvin & Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States