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

NCT ID: NCT03713021

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2021-02-17

Brief Summary

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.

Conditions

Oropharyngeal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TraceIT Tissue Marker

Intervention Type: DEVICE

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

Interventions

TraceIT Tissue Marker

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

Intervention Type: DEVICE

Other Intervention Names

TraceIT hydrogel

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan S Jackson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

201810117

Identifier Type: -

Identifier Source: org_study_id