Tongue TumorNCT04041141
Oral Stent Device for Radiation Treatments of Oral Cancers
An observational study of Tongue Tumor and Tongue Cancer, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tongue Tumor, Tongue Cancer
- What is being tested?
- CT Scan and Experimental Oral Stent Device
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2019to 3 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥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)
Who cannot join
- History of bleeding disorder
- History of allergy to dental grade material
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: A Pilot Study Assessing an Oral Stent Device for Radiation Treatments of Oral Cancers
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
- Being tested
- CT Scan, Experimental Oral Stent Device
- Keywords
- tongue tumor, tongue cancer, oral cancer
- Medical subject headings
- Tongue Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT ScanDiagnostic test
An additional cone beam CT will be repeated at midcourse of therapy (3rd week) and during the end of therapy (5th week)
Experimental Oral Stent DeviceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Oral Cancer | Patients receiving curative radiation treatment for an oral cancer. Receives: Diagnostic Test: CT Scan; Device: Experimental Oral Stent Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The volume of mandible irradiated to >55 Gy
Measured: volume irradiated at Day 0
Secondary outcomes (1)
The position of the fiducial marker
Fiducial coordinate measured (mm) on XYZ on planning CT
Measured: Change in position at Day 0, Week 3, Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start25 Sep 2019
- Primary completion3 Feb 2021
- Study completion3 Feb 2021
Why it stopped: replaced with other study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tongue TumorStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Langer, Indiana University
- Investigators
- Mark Langer, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041141
- Sponsor's protocol ID
- IUSCC-0687
- Status last verified
- Feb 2021
- First submitted
- 11 Jul 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing an Oral Stent Device for Radiation Treatments of Oral Cancers
- ClinicalTrials.gov ID
- NCT04041141
- Acronym / sponsor ID
- IUSCC-0687
- Conditions
- Tongue Tumor, Tongue Cancer
- Keywords
- tongue tumor, tongue cancer, oral cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: replaced with other study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Cancer | – | Diagnostic Test: CT Scan, Device: Experimental Oral Stent DevicePatients receiving curative radiation treatment for an oral cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (2 listed)
- History of bleeding disorder
- History of allergy to dental grade material
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT ScanAn additional cone beam CT will be repeated at midcourse of therapy (3rd week) and during the end of therapy (5th week) | Diagnostic test | Oral Cancer |
| Experimental Oral Stent DevicePatients 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 | Device | Oral Cancer |
Primary outcome
The volume of mandible irradiated to >55 Gy
Time frame: volume irradiated at Day 0
1 secondary outcome
The position of the fiducial marker
Time frame: Change in position at Day 0, Week 3, Week 5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
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Active, not recruitingPhase 2
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A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Langer, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tongue Tumor and Tongue Cancer, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The volume of mandible irradiated to >55 Gy (time frame: volume irradiated at Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.