search
Back to results

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

Primary Purpose

Oropharyngeal Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TraceIT Tissue Marker
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Oropharyngeal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TraceIT Tissue Marker

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection
Anatomic Localization Related to Standard Treatment Fields Based on Anatomy as Measured by Number of Participants That Had Markers Visible

Full Information

First Posted
October 15, 2018
Last Updated
July 11, 2022
Sponsor
Washington University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT03713021
Brief Title
TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers
Official Title
Evaluation of TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Equipment unavailable
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
February 17, 2021 (Actual)
Study Completion Date
February 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TraceIT Tissue Marker
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TraceIT Tissue Marker
Other Intervention Name(s)
TraceIT hydrogel
Intervention Description
The maximum injection volume of TraceIT hydrogel, for a single location, is 1mL.
Primary Outcome Measure Information:
Title
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
Description
-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 Outcome Measure Information:
Title
Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection
Time Frame
From time of injection through surgery (day 1)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan S Jackson, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

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

We'll reach out to this number within 24 hrs