A Study of Lymphoseek® as a Lymphoid Tissue Targeting Age... | NCT02509598

NCT02509598

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tc99m tilmanocept and Vital Blue Dye (optional)	Experimental	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care).	Drug: Tc99m tilmanocept Drug: Vital Blue Dye (optional) Procedure: Lymph Node Mapping

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tc99m tilmanocept	Drug	A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery	Tc99m tilmanocept and Vital Blue Dye (optional)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average Number of Lymph Nodes Identified Intraoperatively Per Subject		1 Day
Subject Localization Rates	The proportion of subjects with Lymphoseek-identified lymph nodes	1 Day

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Subjects Who Underwent Preoperative SPECT or SPECT/CT		1 Day
Proportion of Subjects With a Lymph Node Identified Preoperatively Using SPECT or SPECT/CT		1 day

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Michael Blue, MD	Cardinal Health 414, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Nemours Children's Specialty Care		Jacksonville	Florida	32207	United States
Nemours Children's Hopsital

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

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	Sep 1, 2017

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Units	Counts
Participants	BG00023

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00011.6± 4.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00015
Male	BG0008

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000

Tumor type

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Melanoma	BG0005
Rhabdomyosarcoma	BG0004

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

Average Number of Lymph Nodes Identified Intraoperatively Per Subject

Posted

Mean

95% Confidence Interval

nodes per subject

1 Day

ID	Title	Description
OG000	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Units	Counts
Participants	OG00023

Title

Denominators

Categories

Title	Measurements
	OG0003.30(1.95 to 4.65)

Primary

Subject Localization Rates

The proportion of subjects with Lymphoseek-identified lymph nodes

Posted

Count of Participants

Participants

1 Day

ID	Title	Description
OG000	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Units	Counts
Participants	OG000

Secondary

Proportion of Subjects Who Underwent Preoperative SPECT or SPECT/CT

Posted

Count of Participants

Participants

1 Day

ID	Title	Description
OG000	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Units	Counts
Participants	OG000

Secondary

Proportion of Subjects With a Lymph Node Identified Preoperatively Using SPECT or SPECT/CT

Number of subjects who underwent preoperative SPECT/CT

Posted

Count of Participants

Participants

1 day

ID	Title	Description
OG000	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Units	Counts
Participants	OG000

Secondary

Average Number of Lymph Nodes Identified Preoperatively Using SPECT or SPECT/CT Per Subject

Posted

Mean

95% Confidence Interval

nodes per subject

1 Day

ID	Title	Description
OG000	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Units	Counts
Participants	OG000

Secondary

Agreement of the Number of Nodes Identified by Preoperative SPECT or SPECT/CT to Intraoperative Localization

Average difference in number of LNs identified preoperatively with SPECT/CR and number of LNs identified intraoperatively per subject

Posted

Mean

95% Confidence Interval

nodes per subject

1 Day

ID	Title	Description
OG000	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Units	Counts
Participants	OG000

Secondary

Upstaging

The proportion of patients with pathology-positive lymph nodes who had at least one pathology-positive lymph node that was identified by Lymphoseek and had no other pathology-positive lymph nodes (i.e., identified by any other method)

Number of subjects with pathology-positive nodes

Posted

Count of Participants

Participants

1 Day

ID	Title	Description
OG000	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Units	Counts
Participants	OG000

Secondary

Nodal False Negative Rate for Nodes Identified

The number of pathology-positive lymph nodes that were missed intraoperatively by mapping agent divided by the total number of pathology-positive lymph nodes for that mapping agent. Population is all subjects with pathology-positive nodes. False negative rate represents the failure rate of the mapping agent to identify sentinel lymph nodes.

Subjects with pathology-positive nodes

Posted

Number

95% Confidence Interval

proportion

1 Day

pathology-positive nodes

ID	Title	Description
OG000	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Units	Counts
Participants

Secondary

Nodal Sensitivity

The number of pathology-positive lymph nodes that were identified intraoperatively by mapping agent divided by the total number of pathology-positive lymph nodes for that mapping agent. Population is all subjects with pathology-positive nodes. Sensitivity rate represents the success rate of the mapping agent to identify sentinel lymph nodes.

Subjects with pathology-positive nodes

Posted

Number

95% Confidence Interval

proportion

1 Day

pathology-positive nodes

ID	Title	Description
OG000	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Units	Counts
Participants

Secondary

Nodal Agreement of Central Pathology Assessment With Local Pathology Assessment of the Excised Lymph Node(s) to Confirm the Presence/Absence of Tumor Metastases

Number of nodes whose local and central pathology results agree divided by the number of nodes with nonmissing local and central pathology results

Posted

Count of Units

Nodes with nonmissing pathology

1 Day

Nodes with nonmissing pathology

ID	Title	Description
OG000	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Units	Counts
Participants	OG000

Secondary

Change in Subject Nodal Staging Before and After Surgery Based Upon Nodes Identified

Change in subject nodal staging was assessed via shift tables to show the number of subjects with each combination of presurgery and postsurgery nodal staging. Presurgery staging was based on standard-of-care clinical assessment. Postsurgery staging was based on the pathology results of the nodes identified.

Posted

Count of Participants

Participants

1 Day

ID	Title	Description
OG000	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Units	Counts
Participants	OG000

Secondary

Number of Changes in Postsurgical Treatment Plan in Relation to Nodes Identified by Lymphoseek

Changes to postsurgical treatment plan will be compared to baseline treatment plan.

Posted

Count of Participants

Participants

1 Day

ID	Title	Description
OG000	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Units	Counts
Participants	OG000

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	Tc99m Tilmanocept and Vital Blue Dye (Optional)	0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). Tc99m tilmanocept: A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery Vital Blue Dye (optional): A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care). Lymph Node Mapping: Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection	0	23	3	23	5	23

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 events1 affected23 at risk
febrile neutropenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0004 events2 affected23 at risk
hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected23 at risk
acute kidney injury	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected23 at risk
pyrexia	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected23 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment		EG0004 affected23 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0003 affected23 at risk

ID	Term
D012208	Rhabdomyosarcoma
D008545	Melanoma

Ancestor Terms

ID	Term
D009217	Myosarcoma
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D012509	Sarcoma
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
C431884	technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran
C025484	iso-sulfan blue