Clinical Trials /

Oral Stent Device for Radiation Treatments of Oral Cancers

NCT04041141

Description:

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.

Related Conditions:
  • Lip and Oral Cavity Carcinoma
Recruiting Status:

Withdrawn

URL:

https://clinicaltrials.gov/show/NCT04041141

Trial Eligibility

Document

Title

  • Brief Title: Oral Stent Device for Radiation Treatments of Oral Cancers
  • Official Title: A Pilot Study Assessing an Oral Stent Device for Radiation Treatments of Oral Cancers

Clinical Trial IDs

  • ORG STUDY ID: IUSCC-0687
  • NCT ID: NCT04041141

Conditions

  • Tongue Tumor
  • Tongue Cancer

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Oral CancerPatients receiving curative radiation treatment for an oral cancer.

    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
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:The volume of mandible irradiated to >55 Gy
    Time Frame:volume irradiated at Day 0
    Safety Issue:
    Description:

    Secondary Outcome Measures

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

    Details

    Phase:
    Primary Purpose:Observational
    Overall Status:Active, not recruiting
    Lead Sponsor:Indiana University

    Trial Keywords

    • tongue tumor
    • tongue cancer
    • oral cancer

    Last Updated

    October 5, 2020