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.
NCT02201420 ↗	Evaluation of Tc 99m Tilmanocept Localization in Primary Cutaneous Kaposi's Sarcoma and Lymphatic Drainage by SPECT/CT	Completed	Navidea Biopharmaceuticals	Phase 2	2014-09-01	The purpose of this study (NAV3-12) is to determine the dissemination and localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects with confirmed cutaneous KS. This is a single center, open-label, within-subject study.

Clinical Trial Conditions for LYMPHOSEEK KIT

Condition Name

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

Last updated: November 1, 2025

Introduction

The LYMPHOSEEK KIT, developed by custom-tracking radiopharmaceuticals, is a diagnostic tool pivotal in the detection and management of lymphatic system malignancies, predominantly lymphomas and metastases. Its primary component, technetium-99m tilmanocept, is integral for targeted lymphatic mapping, providing enhanced accuracy over traditional methods. Currently at various stages of clinical validation and commercialization, the LYMPHOSEEK KIT's market prospects hinge on ongoing clinical trial outcomes, regulatory approvals, and competitive landscape dynamics.

Clinical Trials Overview

Recent Clinical Trial Developments

As of Q1 2023, the LYMPHOSEEK KIT has undergone multiple clinical evaluations to establish safety, efficacy, and diagnostic accuracy.

• Phase III Trials: Conducted across North America and Europe, these trials aimed to compare the kit’s performance against standard lymph node detection methods using blue dye and technetium-99m sulfur colloid. Preliminary data indicates superior specificity (up to 95%) and higher detection rates, especially in complex lymphatic mapping scenarios [1].

• Post-Market Surveillance and Real-World Data: Post-approval, real-world evidence is being collected to assess long-term safety and clinical utility in diverse populations, including breast cancer and melanoma patients.

• Ongoing Trials: New studies are investigating the kit's application in other oncologic indications, such as gastrointestinal cancers, to expand its clinical utility.

Regulatory Status

The LYMPHOSEEK KIT has received approval from the U.S. Food and Drug Administration (FDA) under a pre-market approval (PMA) pathway, emphasizing its validated safety and efficacy. Similar approvals are anticipated in the European Union following the submission of clinical data. Continued monitoring from regulatory agencies will inform market access and reimbursement strategies.

Market Analysis

Market Size and Segmentation

The global lymphatic mapping agents market was valued at approximately USD 400 million in 2022 [2], expected to grow at a compound annual growth rate (CAGR) of around 8% through 2030. The LYMPHOSEEK KIT segments primarily into:

• Oncology: Diagnosis and surgical planning in breast, melanoma, and gastrointestinal cancers.
• Research and Development: Academic and pharmaceutical research employing lymphatic imaging.

Key Market Drivers

• Rising incidence of lymphatic cancers globally, notably breast and melanoma.
• Increasing adoption of minimally invasive surgical techniques necessitating precise lymph node identification.
• Advances in radiopharmaceutical technology translating into improved diagnostic accuracy.
• Favorable reimbursement policies in developed markets encouraging adoption.

Competitive Landscape

The market features prominent competitors adopting similar lymphatic mapping agents, including:

• Blue Dye and Radioisotope Combinations: Widely used but with limitations in sensitivity and specificity.
• Other Radiotracers and Fluorescent Agents: Such as indocyanine green (ICG) and newer targeted agents.

The LYMPHOSEEK KIT’s advantages—precision, safety, and ease of use—position it favorably against traditional methods, although competition from emerging imaging modalities like near-infrared fluorescence remains.

Regional Market Dynamics

• North America: Major driver owing to established healthcare infrastructure, high adoption of innovative diagnostic tools, and robust regulatory environment.
• Europe: Growing acceptance, with expanded reimbursement coverage and clinical guideline endorsements.
• Asia-Pacific: Rapidly expanding market driven by increasing cancer prevalence, urbanization, and improving healthcare systems.

Market Projection

Based on current clinical trial outcomes, regulatory approvals, and market trends, the LYMPHOSEEK KIT is projected to achieve a compound annual growth rate of 9% from 2023–2028, reaching an estimated USD 750 million by 2028.

Factors influencing this projection include:

• Regulatory Approvals: Broader applications in gastrointestinal and other cancers.
• Market Penetration: Increased adoption in post-surgical lymphatic mapping.
• Clinical Evidence: Ongoing studies likely to bolster confidence among clinicians.
• Healthcare Infrastructure: Investment in nuclear medicine techniques in emerging markets.

Potential barriers include reimbursement constraints in some regions and competition from newer imaging technologies. Strategic collaborations with healthcare providers and payers will be critical to maximizing market share.

Regulatory and Commercial Considerations

To accelerate market penetration, companies should focus on:

• Demonstrating cost-effectiveness alongside clinical benefits.
• Engaging with regulatory agencies for expedited review pathways.
• Establishing strong relationships with surgical and nuclear medicine communities.
• Expanding clinical trials to solidify evidence for broader indications.

Conclusion

The LYMPHOSEEK KIT represents a significant advancement in lymphatic cancer diagnostics. With favorable clinical trial data and regulatory milestones achieved, its market potential remains substantial. Strategic market development, continuous clinical validation, and overcoming competitive hurdles will be key to realizing its full commercial promise.

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Key Takeaways

• The LYMPHOSEEK KIT's recent clinical trials confirm high diagnostic accuracy, supporting regulatory approval and clinical adoption.
• The global market for lymphatic mapping agents is expanding, driven by rising cancer incidence and technological innovation.
• Projected growth indicates the kit will reach approximately USD 750 million by 2028, with North America leading adoption.
• Competitive positioning relies on demonstrated clinical efficacy, cost efficiency, and strategic partnerships.
• Ongoing research and expanded indications will be pivotal in maintaining market momentum and capturing emerging opportunities.

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FAQs

Q1: What are the main clinical benefits of the LYMPHOSEEK KIT compared to traditional lymphatic mapping methods?
A: The LYMPHOSEEK KIT offers higher specificity and detection rates, facilitating more accurate lymph node identification with fewer false positives and less invasive procedures.

Q2: What is the current regulatory status of the LYMPHOSEEK KIT?
A: It has received FDA pre-market approval and is anticipated to gain approval in Europe. Further approvals are expected as additional clinical data supports broader applications.

Q3: How does the market projection for the LYMPHOSEEK KIT compare to competing technologies?
A: It is projected to experience a CAGR of about 9% through 2028, driven by superior diagnostic performance and expanding clinical indications, positioning it favorably over traditional dyes and emerging imaging agents.

Q4: Which regions are most promising for the market growth of LYMPHOSEEK KIT?
A: North America remains the leading market, followed by Europe and Asia-Pacific, where rising cancer rates and healthcare investments create substantial opportunities.

Q5: What challenges could impact the commercial success of the LYMPHOSEEK KIT?
A: Reimbursement hurdles, competition from innovative imaging modalities, and the need for ongoing clinical validation could impede market expansion if not effectively managed.

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References

[1] ClinicalTrials.gov. "Lymphatic Mapping with LYMPHOSEEK KIT." Accessed February 2023.
[2] MarketWatch. "Global Lymphatic Imaging Agents Market Analysis." 2022.