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

NCT03713021 | Terminated Results DMC FDA Device

• 1 other identifier: 201810117
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection

  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

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

Study Arms (1)

TraceIT Tissue Marker

EXPERIMENTAL

* 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.

Device: TraceIT Tissue Marker

Interventions

TraceIT Tissue Marker DEVICE

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

Also known as: TraceIT hydrogel

TraceIT Tissue Marker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Ryan Jackson, M.D.
• Organization: Washington University School of Medicine

jackson.ryan@wustl.edu

314-362-0365

Study Officials

• Ryan S Jackson, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 19, 2018
• Study Start: May 15, 2019
• Primary Completion: February 17, 2021
• Study Completion: February 17, 2021
• Last Updated: July 12, 2022
• Results First Posted: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)