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

Washington University School of Medicine27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Oropharyngeal Cancer

Interventions

TraceIT Tissue MarkerDEVICE

The maximum injection volume of TraceIT hydrogel, for a single location, is 1mL.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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.

Time frame: At the treatment planning (2-5 weeks after TraceIT hydrogel placement)

Secondary Outcomes

Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection

Time frame: 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

Time frame: At the treatment planning (2-5 weeks after TraceIT hydrogel placement)

Data from ClinicalTrials.gov

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