Trial Outcomes & Findings for Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes (NCT NCT01106040)

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

163 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 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
Overall Study STARTED	163
Overall Study COMPLETED	152
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lymphoseek n=153 Participants Enrolled patients who were administered any injection of Lymphoseek.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	101 Participants n=93 Participants
Age, Categorical >=65 years	52 Participants n=93 Participants
Age Continuous	59.3 years STANDARD_DEVIATION 12.4 • n=93 Participants
Sex: Female, Male Female	104 Participants n=93 Participants
Sex: Female, Male Male	49 Participants n=93 Participants
Region of Enrollment United States	153 participants n=93 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/non-lymphatic) 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=229 Lymph Nodes Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
Concordance of Blue Dye and Lymphoseek	1.0000 Proportion of Lymph Nodes Interval 0.984 to 1.0

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=378 Lymph Nodes Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
Reverse Concordance of Blue Dye and Lymphoseek	0.6058 Proportion of Lymph Nodes Interval 0.5546 to 0.6554

Adverse Events

Lymphoseek

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lymphoseek n=153 participants at risk Enrolled patients who were administered any injection of Lymphoseek.
Cardiac disorders Bradycardia	0.65% 1/153 • Number of events 1
Cardiac disorders Tachycardia	0.65% 1/153 • Number of events 1
Infections and infestations Cellulitis	1.3% 2/153 • Number of events 2
Infections and infestations Herpes Zoster Ophthalmic	0.65% 1/153 • Number of events 1
Injury, poisoning and procedural complications Seroma	0.65% 1/153 • Number of events 1
Nervous system disorders Syncope	0.65% 1/153 • Number of events 1
Respiratory, thoracic and mediastinal disorders Asthma	0.65% 1/153 • Number of events 1

Other adverse events

Adverse event data not reported

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