TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers

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.

Inclusion Criteria:

• Pathologically confirmed (by routine H&E staining) or highly suspicious for 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:

• Distant 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 radiation therapy trial that has not completed its primary endpoint or that clinically interferes with this study.
• Poor surgical candidate
• Prisoners