NCT03713021

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	TraceIT Tissue Marker	The maximum injection volume of TraceIT hydrogel, for a single location, is 1mL.

Timeline

• Start date: 2019-05-15
• Primary completion: 2021-02-17
• Completion: 2021-02-17
• First posted: 2018-10-19
• Last updated: 2022-07-12
• Results posted: 2022-07-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study