Working… Menu

Oral Stent Device for Radiation Treatments of Oral Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04041141
Recruitment Status : Withdrawn (replaced with other study)
First Posted : August 1, 2019
Last Update Posted : February 9, 2021
Information provided by (Responsible Party):
Mark Langer, 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.

Condition or disease Intervention/treatment
Tongue Tumor Tongue Cancer Diagnostic Test: CT Scan Device: Experimental Oral Stent Device

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study Assessing an Oral Stent Device for Radiation Treatments of Oral Cancers
Actual Study Start Date : September 25, 2019
Actual Primary Completion Date : February 3, 2021
Actual Study Completion Date : February 3, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

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

Primary Outcome Measures :
  1. The volume of mandible irradiated to >55 Gy [ Time Frame: volume irradiated at Day 0 ]

Secondary Outcome Measures :
  1. The position of the fiducial marker [ Time Frame: Change in position at Day 0, Week 3, Week 5 ]
    Fiducial coordinate measured (mm) on XYZ on planning CT

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04041141

Layout table for location information
United States, Indiana
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Layout table for investigator information
Principal Investigator: Mark Langer, MD Indiana University
Layout table for additonal information
Responsible Party: Mark Langer, Professor of Clinical Radiation Oncology, Indiana University Identifier: NCT04041141    
Other Study ID Numbers: IUSCC-0687
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark Langer, Indiana University:
tongue tumor
tongue cancer
oral cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Mouth Neoplasms
Tongue Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Tongue Diseases