TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers
Oropharyngeal Cancer
About this trial
This is an interventional diagnostic trial for Oropharyngeal Cancer
Eligibility Criteria
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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Experimental
TraceIT Tissue Marker
Following successful tumor resection, TraceIT Tissue Marker will be applied in 0.2 to 0.5 mL injections at 5 locations to mark the tumor bed: superiorly, inferiorly, laterally, medially, and center of resection. The marginal injections will be within 3 mm of the resection edge and within 5 mm deep. The center of the resection bed will be injected within 5 mm deep if possible. Within 6 weeks after surgery, a CT simulation scan will be performed per normal protocol for patients receiving surgery followed by adjuvant therapy. This scan will be used to generate the intensity-modulated radiation therapy (IMRT) treatment plan Two treatment plans will be performed per patient using the simulation CT scan. One will be the standard of care treatment plan and will be the basis of the actual radiation treatment they receive. The second treatment plan will be based on utilizing the TraceIT hydrogel markers as a guide for the resection bed.