Oral Stent Device for Radiation Treatments of Oral Cancers

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Tongue Cancer; Tongue Tumor
• Intervention / Treatment: Diagnostic test: CT Scan; Device: Experimental Oral Stent Device

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin & Bren Simon Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Potential patients will be identified in the Oncology outpatient clinics or by referrals from outside physicians at the Indiana University Simon Cancer Center.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Oral Cancer; Patients receiving curative radiation treatment for an oral cancer.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The volume of mandible irradiated to >55 Gy	volume irradiated at Day 0

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Mark Langer, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): February 3, 2021
• Study Completion (Actual): February 3, 2021

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: tongue cancer; oral cancer; tongue tumor
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Tongue Diseases; Mouth Neoplasms; Tongue Neoplasms
• Other Study ID Numbers: IUSCC-0687

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No