Trial Outcomes & Findings for TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers (NCT NCT03713021)
NCT ID: NCT03713021
Last Updated: 2022-07-12
Results Overview
-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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
At the treatment planning (2-5 weeks after TraceIT hydrogel placement)
Results posted on
2022-07-12
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Did not have CT sim scan available
|
6
|
|
Overall Study
Not eligible
|
4
|
|
Overall Study
Issues with TraceIT markers
|
5
|
Baseline Characteristics
TraceIT Tissue Marker to Mark the Primary Resection Bed Margins of Oropharyngeal Cancers
Baseline characteristics by cohort
| Measure |
TraceIT Tissue Marker
n=27 Participants
* 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.
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
-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.
Outcome measures
| Measure |
TraceIT Tissue Marker
n=12 Participants
* 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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
Outcome measures
| Measure |
TraceIT Tissue Marker
n=14 Participants
* 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.
|
|---|---|
|
Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection
|
0 Participants
|
SECONDARY outcome
Timeframe: At the treatment planning (2-5 weeks after TraceIT hydrogel placement)Population: 21 out of 27 participants had CT sim scans available.
Outcome measures
| Measure |
TraceIT Tissue Marker
n=21 Participants
* 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.
|
|---|---|
|
Anatomic Localization Related to Standard Treatment Fields Based on Anatomy as Measured by Number of Participants That Had Markers Visible
|
15 Participants
|
Adverse Events
TraceIT Tissue Marker
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ryan Jackson, M.D.
Washington University School of Medicine
Phone: 314-362-0365
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place