TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | February 28, 2019 |
| End Date: | April 30, 2020 |
| Contact: | Ryan S Jackson, M.D. |
| Email: | jackson.ryan@wustl.edu |
| Phone: | 314-362-0365 |
Evaluation of TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers: a Pilot Study
The purpose of this research study is to look at how using an injectable marker called
TraceIT can help with the radiation treatment planning process. TraceIT is a gel that
dissolves in the body over time and can be injected and is visible on many types of images
that can be used in the treatment planning process. If the exact edges of negative tumor
margins can be marked before treatment planning, it is thought that the area receiving
radiation can be more personalized, thus potentially reducing unnecessary radiation to areas
that are cancer-free.
TraceIT can help with the radiation treatment planning process. TraceIT is a gel that
dissolves in the body over time and can be injected and is visible on many types of images
that can be used in the treatment planning process. If the exact edges of negative tumor
margins can be marked before treatment planning, it is thought that the area receiving
radiation can be more personalized, thus potentially reducing unnecessary radiation to areas
that are cancer-free.
Inclusion Criteria:
- Pathologically confirmed (by routine H&E staining) oropharyngeal squamous cell cancer.
- Planned treatment includes transoral surgery followed by adjuvant intensity modulated
radiation therapy (IMRT).
- At least 18 years of age.
- Ability to understand and willingness to sign an IRB approved written informed consent
document.
Exclusion Criteria:
- Metastatic disease at the time of definitive treatment, and thus study, initiation.
- History of major head & neck surgery or previous head & neck irradiation.
- History of or current oral disease that may interfere with interpretation of study
outcomes.
- Currently enrolled in another investigational drug or device trial that has not
completed its primary endpoint or that clinically interferes with this study.
- A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to TraceIT or other agents used in the study.
- Uncontrolled concurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac
arrhythmia, thus making the patient a poor surgical candidate.
- Prisoners.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Ryan S Jackson, M.D.
Phone: 314-362-0365
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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