Oral Stent Device for Radiation Treatments of Oral Cancers
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|ClinicalTrials.gov Identifier: NCT04041141|
Recruitment Status : Withdrawn (replaced with other study)
First Posted : August 1, 2019
Last Update Posted : February 9, 2021
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|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|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|
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
- The volume of mandible irradiated to >55 Gy [ Time Frame: volume irradiated at Day 0 ]
- 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
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
|United States, Indiana|
|Indiana University Melvin & Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Mark Langer, MD||Indiana University|