Trial Outcomes & Findings for Trial of Lymphoseek in Intraoperative Localization of Lymph Nodes in Breast Cancer and Melanoma (NCT NCT00671918)

Results Overview

The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

186 participants

Primary outcome timeframe

Surgery after injections of Lymphoseek and blue dye

Results posted on

2013-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	Lymphoseek, Lymphatic Mapping, Injection Melanoma and breast cancer patients to receive a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc-99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
Overall Study STARTED	186
Overall Study COMPLETED	169
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Lymphoseek in Intraoperative Localization of Lymph Nodes in Breast Cancer and Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lymphoseek n=179 Participants Enrolled patients who were administered any injection of Lymphoseek.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	120 Participants n=99 Participants
Age, Categorical >=65 years	59 Participants n=99 Participants
Age Continuous	58.5 years STANDARD_DEVIATION 14.1 • n=99 Participants
Sex: Female, Male Female	128 Participants n=99 Participants
Sex: Female, Male Male	51 Participants n=99 Participants
Region of Enrollment United States	161 participants n=99 Participants
Region of Enrollment Israel	18 participants n=99 Participants

PRIMARY outcome

Timeframe: Surgery after injections of Lymphoseek and blue dye

Population: All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node stained intraoperatively by blue dye, and for whom the tissue type (lymphatic/nonlymphatic) and pathology status (presence/absence of tumor cells) was confirmed.

The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.

Outcome measures

Outcome measures
Measure	Intent-To-Treat n=215 Lymph Nodes Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
Concordance of Blue Dye and Lymphoseek	0.9767 Proportion of Lymph Nodes Interval 0.9466 to 0.9924

SECONDARY outcome

Timeframe: Surgery after injections of Lymphoseek and blue dye

Population: All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node detected by Lymphoseek (at ≥ 3σ count) in vivo, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.

The proportion of lymph nodes detected intraoperatively by Lymphoseek that were also detected by blue dye.

Outcome measures

Outcome measures
Measure	Intent-To-Treat n=306 Lymph Nodes Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
Reverse Concordance of Blue Dye and Lymphoseek	0.6863 Proportion of Lymph Nodes Interval 0.631 to 0.7379

Adverse Events

Lymphoseek

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lymphoseek n=179 participants at risk Enrolled patients who were administered any injection of Lymphoseek.
Cardiac disorders Myocardial Infarction	0.56% 1/179 • Number of events 1
Gastrointestinal disorders Nausea	0.56% 1/179 • Number of events 1
Gastrointestinal disorders Vomiting	0.56% 1/179 • Number of events 1
Infections and infestations Cellulitis	0.56% 1/179 • Number of events 1
Surgical and medical procedures Modified Radical Mastectomy	0.56% 1/179 • Number of events 1

Other adverse events

Other adverse events
Measure	Lymphoseek n=179 participants at risk Enrolled patients who were administered any injection of Lymphoseek.
Gastrointestinal disorders Nausea	5.6% 10/179 • Number of events 10

Additional Information

Dr. Frederick Cope

Navidea Biopharmaceuticals

Phone: 614-793-7500

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