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Trial record 2 of 7039 for:    Oral Cancer | ( Map: United States )

Oral Stent Device for Radiation Treatments of Oral Cancers

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ClinicalTrials.gov Identifier: NCT04041141
Recruitment Status : Not yet recruiting
First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
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

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study Assessing an Oral Stent Device for Radiation Treatments of Oral Cancers
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 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

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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.
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

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 ClinicalTrials.gov identifier (NCT number): NCT04041141


Contacts
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Contact: Mark Langer, MD 317-944-2524 mlanger@iupui.edu
Contact: Amy Miller 317-278-7614 amym@iu.edu

Locations
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United States, Indiana
Indiana University Melvin & Bren Simon Cancer Center Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Amy Miller    317-278-7614    amym@iu.edu   
Principal Investigator: Mark Langer, MD         
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Mark Langer, MD Indiana University

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Responsible Party: Mark Langer, Professor of Clinical Radiation Oncology, Indiana University
ClinicalTrials.gov Identifier: NCT04041141     History of Changes
Other Study ID Numbers: IUSCC-0687
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

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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:
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Mouth Neoplasms
Tongue Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Tongue Diseases