- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03713021
TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers
July 11, 2022 updated by: Washington University School of Medicine
Evaluation of TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers: a Pilot Study
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TraceIT Tissue Marker
|
The maximum injection volume of TraceIT hydrogel, for a single location, is 1mL.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: At the treatment planning (2-5 weeks after TraceIT hydrogel placement)
|
-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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection
Time Frame: From time of injection through surgery (day 1)
|
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
Time Frame: At the treatment planning (2-5 weeks after TraceIT hydrogel placement)
|
At the treatment planning (2-5 weeks after TraceIT hydrogel placement)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ryan S Jackson, M.D., Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 15, 2019
Primary Completion (ACTUAL)
February 17, 2021
Study Completion (ACTUAL)
February 17, 2021
Study Registration Dates
First Submitted
October 15, 2018
First Submitted That Met QC Criteria
October 18, 2018
First Posted (ACTUAL)
October 19, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 12, 2022
Last Update Submitted That Met QC Criteria
July 11, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201810117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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