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NCT04041141 Clinical Trial

Oral Stent Device for Radiation Treatments of Oral Cancers

Tongue Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04041141
Other study ID # IUSCC-0687
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 25, 2019
Est. completion date February 3, 2021

Study information
Verified date February 2021
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 3, 2021
Est. primary completion date February 3, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Indiana University Melvin & Bren Simon Cancer Center Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The volume of mandible irradiated to >55 Gy volume irradiated at Day 0
Secondary 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
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