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

Oropharyngeal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03713021
• Other study ID #: 201810117
• Status: Terminated
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: February 17, 2021

Study information

• Verified date: July 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: February 17, 2021
• Est. primary completion date: February 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Device:
• TraceIT Tissue Marker
The maximum injection volume of TraceIT hydrogel, for a single location, is 1mL.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection		From time of injection through surgery (day 1)
Secondary	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)

External Links

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