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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Mouth Neoplasms
• Tongue Cancer
• Tongue Neoplasms
• Tongue Tumor

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