Oral Stent Device for Radiation Treatments of Oral Cancers

NCT04041141 | Withdrawn DMC

• 1 other identifier: IUSCC-0687
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Tongue Tumor; Tongue Cancer

Keywords

tongue tumor; tongue cancer; oral cancer

Outcome Measures

Primary Outcomes (1)

• The volume of mandible irradiated to >55 Gy

  volume irradiated at Day 0

Secondary Outcomes (1)

• The position of the fiducial marker

  Change in position at Day 0, Week 3, Week 5

Study Arms (1)

Oral Cancer

Patients receiving curative radiation treatment for an oral cancer.

Diagnostic Test: CT Scan; Device: Experimental Oral Stent Device

Interventions

CT Scan DIAGNOSTIC_TEST

An additional cone beam CT will be repeated at midcourse of therapy (3rd week) and during the end of therapy (5th week)

Oral Cancer

Experimental Oral Stent Device 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

Oral Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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)

You may not qualify if:

• History of bleeding disorder
• History of allergy to dental grade material

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Tongue Neoplasms; Mouth Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Mark Langer, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Radiation Oncology

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: August 1, 2019
• Study Start: September 25, 2019
• Primary Completion: February 3, 2021
• Study Completion: February 3, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

US (1)