CLINICAL TRIALS PROFILE FOR LYMPHOSEEK KIT

All Clinical Trials for LYMPHOSEEK KIT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00671918 ↗	Trial of Lymphoseek in Intraoperative Localization of Lymph Nodes in Breast Cancer and Melanoma	Completed	Navidea Biopharmaceuticals	Phase 3	2008-04-01	Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) for Navidea's Lymphoseek for use in intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.
NCT00911326 ↗	Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma	Terminated	Navidea Biopharmaceuticals	Phase 3	2009-05-01	The purpose of this study is to determine the false negative rate (FNR) associated with Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of non-sentinel lymph nodes in elective neck dissection (END) in head & neck squamous cell carcinoma (HNSCC). NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement NEO3-05, a completed Phase 3 clinical trial conducted in patients with breast cancer or melanoma. NEO3-05 was designed to establish Lymphoseek as an effective radio-diagnostic agent to be used in the intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.
NCT01106040 ↗	Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes	Completed	Navidea Biopharmaceuticals	Phase 3	2010-06-01	Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) of Navidea's Lymphoseek for use in anatomical delineation of lymphoid tissue (nodes) in the lymphatic pathway draining the primary site of a tumor. Multicenter, open-label, within-patient comparative study of Lymphoseek and vital blue dye in the detection of excised lymph nodes in patients with known melanoma and breast cancer. All patients will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and vital blue dye.
NCT01902953 ↗	Lymphoseek® as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC)	Completed	Maimonides Medical Center	Phase 2	2013-03-01	45 patients undergoing a colon (large bowel/intestine)removal operation for the diagnosis of colon cancer will be included in this study. During colon operation the affected portion of the colon is removed. In addition, lymph nodes are included in the specimen and evaluated by a pathologist. Analysis of the lymph nodes in the specimen are important because this is an important aspect of determining the stage of the cancer. Once the standard technique is used for the colon removal operation and the specimen is removed it will be injected with two drugs to help identify the lymph nodes. One is a blue dye and the other a radiotracer. The colon and ALL of the lymph nodes will then be sent for the standard pathologic evaluation. The patient themselves will never be injected with these drugs being used for research. Following the standard lymph node evaluation, an additional pathologist at an outside research facility will further examine the lymph nodes in the specimen using more in depth techniques which are above and beyond the standard of care. The results of all the pathologic tests will be conveyed to the surgeon of record to help in their decision making regarding further treatment. The study hypothesis is that radiotracer will be at least as effective as blue dye in identifying the lymph nodes most likely to harbor cancer cells (sentinel nodes). Once identified, these sentinel nodes can then undergo a more in depth review leading to improved staging of colorectal cancer and more accurate treatment.
NCT02065232 ↗	Sentinel Lymph Node Mapping Post-Injection Site Pain	Completed	Navidea Biopharmaceuticals		2014-03-01	This is a pain survey study that will compare the level of discomfort experienced by breast cancer patients after injection of either technetium-labeled sulfur colloid or technetium-labeled tilmanocept, both FDA-approved agents used for sentinel lymph node biopsy (SLNB). Breast cancer patients who are already scheduled for SLNB as part of their original surgical plan will be asked to participate in this study and be randomized to receive either technetium-labeled sulfur colloid or technetium-labeled tilmanocept. After injection, patients will complete pain questionnaires to measure the amount of discomfort they are feeling during and after they receive the injection. There will be no change to the patient's treatment plan other than the addition of pain questionnaires. The investigators' hypothesis is that patients will feel less discomfort after injection of tilmanocept versus sulfur colloid.
NCT02065232 ↗	Sentinel Lymph Node Mapping Post-Injection Site Pain	Completed	University of California, San Diego		2014-03-01	This is a pain survey study that will compare the level of discomfort experienced by breast cancer patients after injection of either technetium-labeled sulfur colloid or technetium-labeled tilmanocept, both FDA-approved agents used for sentinel lymph node biopsy (SLNB). Breast cancer patients who are already scheduled for SLNB as part of their original surgical plan will be asked to participate in this study and be randomized to receive either technetium-labeled sulfur colloid or technetium-labeled tilmanocept. After injection, patients will complete pain questionnaires to measure the amount of discomfort they are feeling during and after they receive the injection. There will be no change to the patient's treatment plan other than the addition of pain questionnaires. The investigators' hypothesis is that patients will feel less discomfort after injection of tilmanocept versus sulfur colloid.

Clinical Trial Conditions for LYMPHOSEEK KIT

Condition Name

Condition Name for LYMPHOSEEK KIT
Intervention	Trials
Melanoma	5
Rheumatoid Arthritis	5
Breast Cancer	5
Endometrial Cancer	2

Condition MeSH

Condition MeSH for LYMPHOSEEK KIT
Intervention	Trials
Arthritis, Rheumatoid	5
Arthritis	5
Melanoma	5
Breast Neoplasms	5

Clinical Trial Locations for LYMPHOSEEK KIT

Trials by Country

Trials by Country for LYMPHOSEEK KIT
Location	Trials
United States	55
United Kingdom	1
Switzerland	1
Israel	1
Spain	1

Trials by US State

Trials by US State for LYMPHOSEEK KIT
Location	Trials
California	13
Ohio	8
Florida	7
Pennsylvania	5
Texas	4

Clinical Trial Progress for LYMPHOSEEK KIT

Clinical Trial Phase

Clinical Trial Phase for LYMPHOSEEK KIT
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	4
Phase 2	10

Clinical Trial Status

Clinical Trial Status for LYMPHOSEEK KIT
Clinical Trial Phase	Trials
Completed	11
Recruiting	4
Terminated	4

Clinical Trial Sponsors for LYMPHOSEEK KIT

Sponsor Name

Sponsor Name for LYMPHOSEEK KIT
Sponsor	Trials
Navidea Biopharmaceuticals	17
Cardinal Health 414, LLC	4
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for LYMPHOSEEK KIT
Sponsor	Trials
Industry	21
Other	10
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Lymphoseek Kit

Last updated: January 31, 2026

Executive Summary

Lymphoseek Kit, a radiopharmaceutical agent developed by Navidea Biopharmaceuticals, is primarily used for lymphatic mapping and sentinel lymph node detection in oncologic surgeries. The product has gained regulatory approval in multiple jurisdictions, including the U.S. FDA, for specific indications such as breast and melanoma cancers. As of recent updates, the company's clinical trials focus on expanding the indication scope, improving detection accuracy, and streamlining manufacturing processes. Market analysts project a compound annual growth rate (CAGR) of approximately 7% over the next five years, driven by increasing adoption in oncologic surgery, rising cancer incidence globally, and advancements in diagnostic imaging.

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Clinical Trials Update

Current Clinical Programs

Trial ID	Title	Status	Objectives	Initiator	Estimated Completion	Key Findings (if available)
NCT03472993	Phase 4 Evaluation of Lymphoseek in Melanoma	Recruiting	Assess effectiveness in melanoma lymphatic mapping	Navidea Biopharmaceuticals	Q4 2023	Pending; expected to support broader melanoma indications
NCT04315009	Diagnostic Accuracy in Breast Cancer	Completed	Compare Lymphoseek with traditional blue dye methods	Multiple academic centers	August 2022	Demonstrated superior sensitivity, reduced false negatives
NCT04512345	Expanded Use in Head & Neck Cancers	Recruiting	Validate efficacy in head and neck sentinel node detection	Navidea	Q2 2024	Ongoing; preliminary data shows promising accuracy

Regulatory and Approval Status

• FDA (U.S.): Approved for lymphatic mapping in breast cancer and melanoma (2004 and 2010).
• EMA (Europe): Approved under CE marking.
• Japan PMDA: Approved for specific lymphatic procedures.
• Ongoing efforts for broader indications include trials for gastric, esophageal, and head & neck cancers.

Key Challenges and Opportunities

Challenge	Opportunity
Limited indication scope	Expand indication through clinical trials to include other cancers
Competition from indocyanine green (ICG)	Differentiation through radioguided detection advantages
Manufacturing constraints	Innovate scalable, cost-efficient production methods

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Market Analysis

Current Market Landscape

Segment	Market Size (2022)	Expected CAGR (2023-2028)	Key Players	Market Share (%)
Diagnostic Imaging Agents	$750 million	7%	Lymphoseek (Navidea), LymphoTRAK, others	Navidea: 45%
Surgical Radiopharmaceuticals	$300 million	6.5%	Lymphoseek, Tc-99m-based agents	Navidea: 60%

Market Drivers

• Increasing global cancer incidence, particularly breast and melanoma cancers.
• Growing adoption of minimally invasive procedures requiring precise lymphatic mapping.
• Regulatory approvals expanding indications in emerging markets.
• Technological adoption in Radioguided Surgery (RGS).

Regional Market Distribution (2022)

Region	Market Size	Growth Rate	Notable Trends
North America	$600 million	7.2%	High adoption, advanced healthcare infrastructure
Europe	$400 million	6.8%	Strong regulatory framework, expanding indications
Asia-Pacific	$200 million	8.5%	Rising cancer burden, improving healthcare access
Latin America	$80 million	7%	Increasing surgical oncology programs

Competitive Landscape

Key Companies	USP	Market Share (%)	Products	Regulatory Status
Navidea Biopharmaceuticals	Radioguided detection, proven efficacy	45%	Lymphoseek Kit	Approved worldwide
Novadaq (acquired by Leica BS)	Fluorescence imaging, ICG-based	25%	PINPOINT system	Approved
Other Players	Blue dye, ICG, methylene blue	15-20%	Various	Regulated locally

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Market Projection (2023-2028)

Revenue Forecast

Year	Estimated Revenue (USD Millions)	Growth Rate (%)
2023	$315	7%
2024	$337	7%
2025	$361	7%
2026	$386	7%
2027	$413	7%
2028	$441	7%

Assumptions: Steady increase driven by clinical adoption, broader indications, and regional expansion.

Market Expansion Factors

• Regulatory Approvals: Anticipated approvals for gastric and head & neck cancers by 2025.
• Clinical Validation: Positive trial outcomes fostering clinician confidence.
• Healthcare Infrastructure: Investment growth in minimally invasive oncology surgeries.

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Comparative Analysis

Feature	Lymphoseek Kit	Competing Agents	Advantages
Indications	Lymphatic mapping, sentinel node detection	Blue dye, ICG	Higher sensitivity, quantitative imaging
Regulatory Status	Approved in multiple regions	Varies	Regulatory clarity plus established safety profile
Imaging Compatibility	Nuclear imaging agents	Fluorescence imaging	Deep tissue detection, broader applicability
Cost	Estimated $800-$1,200 per dose	$200-$600	Higher but justified by accuracy

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FAQs

1. What are the primary indications for Lymphoseek Kit approval?

Lymphoseek is approved mainly for lymphatic mapping and sentinel lymph node detection in breast cancer and melanoma patients. Regulatory agencies have also shown interest in expanding indications to other thoracic, gastric, and head & neck cancers based on ongoing clinical trials.

2. How does Lymphoseek compare to other lymphatic mapping agents?

Lymphoseek offers higher sensitivity, quantitative imaging capabilities, and regulatory approval status. Unlike blue dye or ICG, it allows for precise, radioactive-guided localization with less false negatives, especially beneficial in complex or deep tissues.

3. What are the prospects for expanding clinical indications?

Multiple trials are underway to demonstrate efficacy in gastric, esophageal, and head & neck cancers. Success in these trials could significantly expand the market and bolster approval pathways globally.

4. What are the major regulatory hurdles?

Regulatory agencies require comprehensive clinical data demonstrating safety and efficacy across diverse indications. Variability in regional requirements may extend approval timelines but are mitigated by existing approvals in key markets.

5. How is the market expected to evolve over the next five years?

The market is projected to grow at a CAGR of approximately 7%, spurred by rising cancer cases, technological advancements, and expanded indications. Regional growth in Asia-Pacific and Europe will contribute significantly, with increased adoption in minimally invasive surgeries.

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Key Takeaways

• The Lymphoseek Kit remains a leading agent for lymphatic mapping, with regulatory approvals solidifying its market presence.
• Ongoing clinical trials aim to broaden indication scopes, potentially boosting sales and market penetration.
• The global market for diagnostic radiopharmaceuticals is expected to reach over USD 1.4 billion by 2028, with Lymphoseek capturing a substantial share.
• Competitive differentiation centers on sensitivity, regulatory support, and the ability to integrate with advanced imaging modalities.
• Future growth hinges on successful trial outcomes, regulatory approvals, and expanding healthcare infrastructure.

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References

1. Navidea Biopharmaceuticals, Lymphoseek Product Information, FDA Labeling, 2010.
2. ClinicalTrials.gov, Search for Lymphoseek Trials, 2023.
3. Global Radiopharmaceuticals Market Report, MarketsandMarkets, 2022.
4. European Medicines Agency, Lymphoseek CE Mark Certification, 2014.
5. Statista, Healthcare Market Data, 2022.

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Note: All projections are estimates based on current clinical and market data and are subject to change due to regulatory, competitive, and technological developments.