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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers: a Pilot Study

Conditions
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Oropharyngeal Cancer

Intervention / Treatment
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* Device: TraceIT Tissue Marker


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TraceIT Tissue Marker<br>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. | Device: TraceIT Tissue Marker<br>* The maximum injection volume of TraceIT hydrogel, for a single location, is 1mL.<br>* Other names: TraceIT hydrogel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Total Mean Clinical Target Volumes (CTV) Between the Standard of Care Treatment Plan and the Treatment Plan Based on the TraceIT Hydrogel Markers | -The mean total dose of each targeted site was totaled from the standard of care treatment plan and the TraceIT tissue marker treatment plan. The percent change in CTV was measured by standard field in cGy minus marker based in cGy = percent change in CTV (in cGy). The sites included left & right submandibular, left & right parotid, left & right pharynx constrictor, oral cavity, lips, larynx, and spinal cord. | At the treatment planning (2-5 weeks after TraceIT hydrogel placement) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection |  | From time of injection through surgery (day 1) | 
| Anatomic Localization Related to Standard Treatment Fields Based on Anatomy as Measured by Number of Participants That Had Markers Visible |  | At the treatment planning (2-5 weeks after TraceIT hydrogel placement) |