Oropharyngeal Cancer
Conditions
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.
Interventions
DEVICETraceIT Tissue Marker
The maximum injection volume of TraceIT hydrogel, for a single location, is 1mL.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
* 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. | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not have CT sim scan available | 6 |
| Overall Study | Issues with TraceIT markers | 5 |
| Overall Study | Not eligible | 4 |
Baseline characteristics
| Characteristic | TraceIT Tissue Marker |
|---|---|
| Age, Continuous | 58 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
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)
Population: 12 participants had both standard of care treatment plans and TraceIT tissue marker treatment plans available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TraceIT Tissue Marker | 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 | Subject 001 | 54.35 percent change in total CTV |
| TraceIT Tissue Marker | 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 | Subject 002 | 54.07 percent change in total CTV |
| TraceIT Tissue Marker | 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 | Subject 003 | -30.40 percent change in total CTV |
| TraceIT Tissue Marker | 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 | Subject 004 | 50.95 percent change in total CTV |
| TraceIT Tissue Marker | 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 | Subject 005 | 53.63 percent change in total CTV |
| TraceIT Tissue Marker | 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 | Subject 006 | 62.53 percent change in total CTV |
| TraceIT Tissue Marker | 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 | Subject 007 | 54.30 percent change in total CTV |
| TraceIT Tissue Marker | 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 | Subject 008 | 60.65 percent change in total CTV |
| TraceIT Tissue Marker | 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 | Subject 009 | 32.96 percent change in total CTV |
| TraceIT Tissue Marker | 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 | Subject 010 | 45.51 percent change in total CTV |
| TraceIT Tissue Marker | 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 | Subject 011 | 29.50 percent change in total CTV |
| TraceIT Tissue Marker | 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 | Subject 012 | 17.60 percent change in total CTV |
Secondary
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)
Population: 21 out of 27 participants had CT sim scans available.
| Arm | Measure | Value (COUNT_OF_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 Participants |
Secondary
Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection
Time frame: From time of injection through surgery (day 1)
Population: 14 out of the enrolled 27 participants received the TraceIT marker and were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TraceIT Tissue Marker | Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection | 0 Participants |