Trial Outcomes & Findings for A Trial of Comparing the Pathology Status of Lymphoseek®-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection (NCT NCT02509585)

Last Updated: 2019-02-11

Results Overview

Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

1 day

Results posted on

2019-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Tc99m Tilmanocept 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial of Comparing the Pathology Status of Lymphoseek®-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tc99m Tilmanocept n=18 Participants Enrolled subjects who were administered any injection of Tc99m tilmanocept.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	38.53 years STANDARD_DEVIATION 7.56 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants
ECOG Status 0	18 Participants n=5 Participants
ECOG Status 1	0 Participants n=5 Participants
ECOG Status 2	0 Participants n=5 Participants
ECOG Status 3	0 Participants n=5 Participants
ECOG Status 4	0 Participants n=5 Participants
ECOG Status 5	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available

Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN

Outcome measures

Outcome measures
Measure	Intent-To-Treat n=18 Participants 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Per-subject False Negative Rate	.333 Proportion of Participants Interval 0.0084 to 0.9057

SECONDARY outcome

Timeframe: 1 day

Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available

Proportion of subjects with at least one pathologically positive Lymphoseek-identified SLN that have at least one pathologically positive lymph node

Outcome measures

Outcome measures
Measure	Intent-To-Treat n=18 Participants 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Per-subject Sensitivity	.667 Proportion of participants Interval 0.0942 to 0.9916

SECONDARY outcome

Timeframe: 1 day

Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available

Proportion of subjects with pathologically negative Lymphoseek-identified SLN(s) with no pathologically positive lymph nodes

Outcome measures

Outcome measures
Measure	Intent-To-Treat n=18 Participants 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Per-subject Negative Predictive Value	.9375 Proportion of participants Interval 0.6977 to 0.9984

SECONDARY outcome

Timeframe: 1 day

Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available

Proportion of subjects accurately indentified by Lymphoseek

Outcome measures

Outcome measures
Measure	Intent-To-Treat n=18 Participants 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Per-subject Accuracy	.9444 Proportion of participants Interval 0.7271 to 0.9986

SECONDARY outcome

Timeframe: 1 day

Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available

Outcome measures

Outcome measures
Measure	Intent-To-Treat n=41 Dye Positive Nodes 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek	.8049 Proportion of Condordant Nodes Interval 0.6513 to 0.9118

SECONDARY outcome

Timeframe: 1 day

Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available

Outcome measures

Outcome measures
Measure	Intent-To-Treat n=49 Total Lymph Nodes 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Number of Lymph Nodes Per-subject Identified by Lymphoseek	2.72 Nodes Per Subject Interval 2.09 to 3.36

SECONDARY outcome

Timeframe: 1 day

Outcome measures

Outcome measures
Measure	Intent-To-Treat n=41 Total Lymph Nodes 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Number of Lymph Nodes Per-subject Identified by Other Dyes	2.41 Nodes Per Subject Interval 1.64 to 3.18

SECONDARY outcome

Timeframe: 1 day

Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available

Subjects whose lymph nodes were determined to be dye positive that were also identified by Lymphoseek

Outcome measures

Outcome measures
Measure	Intent-To-Treat n=15 Dye Positive Nodes 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Per-subject Concordance	1.0 Proportion of Condordant Subjects Interval 0.7819 to 1.0

SECONDARY outcome

Timeframe: 1 day

Population: Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available

Number of subjects whose lymph nodes that were identified by Lymphoseek were also all identified by dye

Outcome measures

Outcome measures
Measure	Intent-To-Treat n=18 Hot Positive Nodes 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Per-subject Reverse Concordance	.8333 Proportion of Reverse Condordant Subj. Interval 0.5858 to 0.9642

SECONDARY outcome

Timeframe: 7 days

Population: Enrolled subjects who were administered any injection of Tc99m tilmanocept.

Outcome measures

Outcome measures
Measure	Intent-To-Treat n=18 Participants 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Tc99m tilmanocept: A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Incidence of Adverse Events	5 Events

Adverse Events

Tc99m Tilmanocept

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tc99m Tilmanocept n=18 participants at risk Enrolled subjects who were administered any injection of Tc99m tilmanocept.
Nervous system disorders Headache	5.6% 1/18 • Number of events 1 • Day of injection through 24 hours post injection
Musculoskeletal and connective tissue disorders Pain in right arm	5.6% 1/18 • Number of events 1 • Day of injection through 24 hours post injection
Gastrointestinal disorders Nausea	5.6% 1/18 • Number of events 1 • Day of injection through 24 hours post injection
Reproductive system and breast disorders Vaginal bleeding	5.6% 1/18 • Number of events 1 • Day of injection through 24 hours post injection
Injury, poisoning and procedural complications Small amount of bleeding at 3:00 injection site	5.6% 1/18 • Number of events 1 • Day of injection through 24 hours post injection

Additional Information

LaTosha Eligon

Cardinal Health

Phone: 913-661-3896

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI shall not submit a publication to journals or professional societies without the prior written approval of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER