TraceIT Tissue Marker to Mark the Primary Resection Bed M... | NCT03713021

TraceIT Tissue Marker to Mark the Primary Resection Bed M... | NCT03713021 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TraceIT Tissue Marker	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
TraceIT Tissue Marker	Device	The maximum injection volume of TraceIT hydrogel, for a single location, is 1mL.	TraceIT Tissue Marker

Outcomes Module

Primary Outcomes

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	-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 Outcomes

Measure	Description	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

Contacts/Locations Module

Name	Affiliation	Role
Ryan S Jackson, M.D.	Washington University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

References Module

Label	URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine	View source

Arm/Group Information

ID	Title	Description
FG000	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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00027 subjects
COMPLETED		FG00012 subjects
NOT COMPLETED		FG00015 subjects

Type	Comment	Reasons
Did not have CT sim scan available		FG0006 subjects
Not eligible		FG0004 subjects
Issues with TraceIT markers		FG0005 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Median

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

12 participants had both standard of care treatment plans and TraceIT tissue marker treatment plans available for this outcome measure.

Posted

Number

percent change in total CTV

At the treatment planning (2-5 weeks after TraceIT hydrogel placement)

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Ryan Jackson, M.D.	Washington University School of Medicine	314-362-0365		jackson.ryan@wustl.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 2, 2019	Nov 29, 2021	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D009959	Oropharyngeal Neoplasms

ID	Term
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000
Native Hawaiian or Other Pacific Islander	BG0000
Black or African American	BG0000
White	BG00027
More than one race	BG0000
Unknown or Not Reported	BG0000

Title

Denominators

Categories

Subject 001

- ParticipantsOG0001

Title	Measurements
	OG00054.35

Subject 002

- ParticipantsOG0001

Title	Measurements
	OG00054.07

Subject 003

- ParticipantsOG0001

Title	Measurements
	OG000-30.40

Subject 004

- ParticipantsOG0001

Title	Measurements
	OG00050.95

Subject 005

- ParticipantsOG0001

Title	Measurements
	OG00053.63

Subject 006

- ParticipantsOG0001

Title	Measurements
	OG00062.53

Subject 007

- ParticipantsOG0001

Title	Measurements
	OG00054.30

Subject 008

- ParticipantsOG0001

Title	Measurements
	OG00060.65

Subject 009

- ParticipantsOG0001

Title	Measurements
	OG00032.96

Subject 010

- ParticipantsOG0001

Title	Measurements
	OG00045.51

Subject 011

- ParticipantsOG0001

Title	Measurements
	OG00029.50

Subject 012

- ParticipantsOG0001

Title	Measurements
	OG00017.60

Secondary

Percentage of Participants Experiencing an Adverse Event Related to TraceIT Injection

14 out of the enrolled 27 participants received the TraceIT marker and were evaluable for this outcome measure.

Posted

Count of Participants

Participants

From time of injection through surgery (day 1)

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG00014

Title

Denominators

Categories

Title	Measurements
	OG0000

Secondary

Anatomic Localization Related to Standard Treatment Fields Based on Anatomy as Measured by Number of Participants That Had Markers Visible

21 out of 27 participants had CT sim scans available.

Posted

Count of Participants

Participants

At the treatment planning (2-5 weeks after TraceIT hydrogel placement)

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG00021

Title

Denominators

Categories

Title	Measurements
	OG00015