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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03713021
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : May 21, 2019
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Oropharyngeal Cancer Device: TraceIT Tissue Marker Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers: a Pilot Study
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : July 31, 2020

Arm Intervention/treatment
Experimental: 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.
  • Between 2 and 5 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 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
The maximum injection volume of TraceIT hydrogel, for a single location, is 1mL.
Other Name: TraceIT hydrogel

Primary Outcome Measures :
  1. Change in clinical target volumes (CTV) for the primary resection bed between the standard of care treatment plan and the treatment plan based on the TraceIT hydrogel markers [ Time Frame: At the treatment planning (2-5 weeks after TraceIT hydrogel placement) ]
    -Reduction in CTV will be measured by standard field in Gy minus marker based in Gy = change in CTV (in Gy)

Secondary Outcome Measures :
  1. Adverse events associated with TraceIT [ Time Frame: Through 2 weeks after the TraceIT hydrogel placement ]
    • The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting
    • Described as frequency and percentage of patients experiencing an adverse event

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pathologically confirmed (by routine H&E staining) 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:

  • 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 investigational drug or device trial that has not completed its primary endpoint or that clinically interferes with this study.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to TraceIT or other agents used in the study.
  • Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia, thus making the patient a poor surgical candidate.
  • Prisoners.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03713021

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Contact: Ryan S Jackson, M.D. 314-362-0365

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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ryan S Jackson, M.D.    314-362-0365   
Principal Investigator: Ryan S Jackson, M.D.         
Sub-Investigator: Wade Thorstad, M.D.         
Sub-Investigator: Hiram Gay, M.D.         
Sub-Investigator: Mackenzie Daly, M.D.         
Sub-Investigator: Jason Rich, M.D.         
Sub-Investigator: Sara Kukuljan, R.N.         
Sub-Investigator: Dorina Kallogjeri, M.D., MPH         
Sponsors and Collaborators
Washington University School of Medicine
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Principal Investigator: Ryan S Jackson, M.D. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine Identifier: NCT03713021     History of Changes
Other Study ID Numbers: 201810117
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases