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

The Washington University

Status: Terminated

Conditions: Oropharyngeal Cancer

Treatments: Device: TraceIT Tissue Marker

Study type: Interventional

Funder types: Other

Identifiers

NCT03713021

201810117

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

TraceIT Tissue Marker

Experimental group

Description:

* 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.

Treatment:

Device: TraceIT Tissue Marker