An interventional study of TraceIT Tissue Marker in Oropharyngeal Cancer, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-12.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Diagnostic
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.
378 studies on the registry are indexed under Oropharyngeal Neoplasms; 99 are open to participants now.
This study's enrollment of 27 is below the median of 47 across 287 interventional studies indexed under Oropharyngeal Neoplasms.
Browse Oropharyngeal Neoplasms studies →Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 271 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.
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Exclusion Criteria:
* 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
The maximum injection volume of TraceIT hydrogel, for a single location, is 1mL.
Also known as: TraceIT hydrogel
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.
Time frame: At the treatment planning (2-5 weeks after TraceIT hydrogel placement)
Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection
Time frame: 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)
| Milestone | TraceIT Tissue Marker |
|---|---|
| Started | 27 |
| Completed | 12 |
| Not completed | 15 |
| Withdrew: Did not have ct sim scan available | 6 |
| Withdrew: Not eligible | 4 |
| Withdrew: Issues with traceit markers | 5 |
-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.
| percent change in total CTV | TraceIT Tissue Marker |
|---|---|
| Subject 001 | 54.35 |
| Subject 002 | 54.07 |
| Subject 003 | -30.40 |
| Subject 004 | 50.95 |
| Subject 005 | 53.63 |
| Subject 006 | 62.53 |
| Subject 007 | 54.30 |
| Subject 008 | 60.65 |
| Subject 009 | 32.96 |
| Subject 010 | 45.51 |
| Subject 011 | 29.50 |
| Subject 012 | 17.60 |
| Participants | TraceIT Tissue Marker |
|---|---|
| Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection | 0 |
| Participants | TraceIT Tissue Marker |
|---|---|
| Anatomic Localization Related to Standard Treatment Fields Based on Anatomy as Measured by Number of Participants That Had Markers Visible | 15 |
Collected over Adverse events were followed from time of TraceIT injection through the intraoperative period (day 1).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TraceIT Tissue Marker | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | TraceIT Tissue Marker |
|---|---|
| Median | 58 (32 to 81) |
| Sex: Female, Male(Participants) | TraceIT Tissue Marker |
|---|---|
| Female | 1 |
| Male | 26 |
| Ethnicity (NIH/OMB)(Participants) | TraceIT Tissue Marker |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 27 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | TraceIT Tissue Marker |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 27 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | TraceIT Tissue Marker |
|---|---|
| United States | 27 |
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