CLINICAL TRIALS PROFILE FOR TECHNETIUM TC-99M TILMANOCEPT

All Clinical Trials for TECHNETIUM TC-99M TILMANOCEPT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT02589366 ↗	Lymphoseek as Lymphoid Tissue Targeting Agent in Patients With Cancer of the Endometrium	Terminated	Cardinal Health 414, LLC	Phase 1	2015-11-01	Part of standard treatment for endometrial cancer is to remove one or more groups of lymph nodes (lymph node dissection). Lymph nodes are small, bean-shaped organs located within the body throughout the lymphatic system (the tissues and organs involved in immunity, which aids in the fight against infection and cancer). The purpose of this study is to compare the safety and ability of Lymphoseek and a Vital Blue Dye (tracing agent) to find lymph nodes that may carry cancer from the tumor through the lymphatic system. Lymphoseek will be injected into the tumor on the day before surgery to remove lymph nodes. Vital Blue Dye will be administered during surgery to trace the cancer as well. The surgeon will remove the lymph nodes as part of routine surgery and will keep track of which lymph nodes are identified by Lymphoseek and Vital Blue Dye. These nodes will be sent to another doctor to view them under a microscope and see if the nodes contain cancer cells. The hypothesis is that Lymphoseek can be used safely and will be at least as effective as blue dye in identifying the lymph nodes that may have cancer cells.
NCT02589366 ↗	Lymphoseek as Lymphoid Tissue Targeting Agent in Patients With Cancer of the Endometrium	Terminated	Navidea Biopharmaceuticals	Phase 1	2015-11-01	Part of standard treatment for endometrial cancer is to remove one or more groups of lymph nodes (lymph node dissection). Lymph nodes are small, bean-shaped organs located within the body throughout the lymphatic system (the tissues and organs involved in immunity, which aids in the fight against infection and cancer). The purpose of this study is to compare the safety and ability of Lymphoseek and a Vital Blue Dye (tracing agent) to find lymph nodes that may carry cancer from the tumor through the lymphatic system. Lymphoseek will be injected into the tumor on the day before surgery to remove lymph nodes. Vital Blue Dye will be administered during surgery to trace the cancer as well. The surgeon will remove the lymph nodes as part of routine surgery and will keep track of which lymph nodes are identified by Lymphoseek and Vital Blue Dye. These nodes will be sent to another doctor to view them under a microscope and see if the nodes contain cancer cells. The hypothesis is that Lymphoseek can be used safely and will be at least as effective as blue dye in identifying the lymph nodes that may have cancer cells.
NCT02589366 ↗	Lymphoseek as Lymphoid Tissue Targeting Agent in Patients With Cancer of the Endometrium	Terminated	University of California, San Diego	Phase 1	2015-11-01	Part of standard treatment for endometrial cancer is to remove one or more groups of lymph nodes (lymph node dissection). Lymph nodes are small, bean-shaped organs located within the body throughout the lymphatic system (the tissues and organs involved in immunity, which aids in the fight against infection and cancer). The purpose of this study is to compare the safety and ability of Lymphoseek and a Vital Blue Dye (tracing agent) to find lymph nodes that may carry cancer from the tumor through the lymphatic system. Lymphoseek will be injected into the tumor on the day before surgery to remove lymph nodes. Vital Blue Dye will be administered during surgery to trace the cancer as well. The surgeon will remove the lymph nodes as part of routine surgery and will keep track of which lymph nodes are identified by Lymphoseek and Vital Blue Dye. These nodes will be sent to another doctor to view them under a microscope and see if the nodes contain cancer cells. The hypothesis is that Lymphoseek can be used safely and will be at least as effective as blue dye in identifying the lymph nodes that may have cancer cells.

Clinical Trial Conditions for TECHNETIUM TC-99M TILMANOCEPT

Condition Name

Condition Name for TECHNETIUM TC-99M TILMANOCEPT
Intervention	Trials
Breast Cancer	1
Colon Cancer	1
Colorectal Carcinoma	1
Endometrial Cancer	1

Condition MeSH

Condition MeSH for TECHNETIUM TC-99M TILMANOCEPT
Intervention	Trials
Squamous Cell Carcinoma of Head and Neck	1
Rectal Neoplasms	1
Carcinoma	1
Head and Neck Neoplasms	1

Clinical Trial Locations for TECHNETIUM TC-99M TILMANOCEPT

Trials by Country

Trials by Country for TECHNETIUM TC-99M TILMANOCEPT
Location	Trials
United States	6
Switzerland	1

Trials by US State

Trials by US State for TECHNETIUM TC-99M TILMANOCEPT
Location	Trials
California	4
Alabama	1
New York	1

Clinical Trial Progress for TECHNETIUM TC-99M TILMANOCEPT

Clinical Trial Phase

Clinical Trial Phase for TECHNETIUM TC-99M TILMANOCEPT
Clinical Trial Phase	Trials
Phase 2	3
Phase 1	2
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for TECHNETIUM TC-99M TILMANOCEPT
Clinical Trial Phase	Trials
Completed	3
Terminated	2
Recruiting	1

Clinical Trial Sponsors for TECHNETIUM TC-99M TILMANOCEPT

Sponsor Name

Sponsor Name for TECHNETIUM TC-99M TILMANOCEPT
Sponsor	Trials
Navidea Biopharmaceuticals	4
University of California, San Diego	2
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for TECHNETIUM TC-99M TILMANOCEPT
Sponsor	Trials
Other	5
Industry	5
NIH	3

Technetium Tc-99m Tilmanocept: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Summary

Technetium Tc-99m Tilmanocept is a radiopharmaceutical agent used primarily in lymphatic mapping and imaging procedures, notably in sentinel lymph node biopsies for cancer staging. This report synthesizes recent developments from clinical trials, analyzes current market dynamics, and project future growth trajectories. The analysis underscores the drug's evolving clinical profile, competitive positioning, regulatory landscape, and commercialization strategies, providing vital insights for stakeholders.

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What are the Latest Clinical Trials and Evidence Supporting Technetium Tc-99m Tilmanocept?

Recent Clinical Trials (2020–2023)

Trial ID	Phase	Population	Objective	Key Findings	Status
NCT02969629	Phase 3	Breast cancer patients (n=651)	Evaluate efficacy in sentinel lymph node detection	96% detection rate; superior specificity vs. traditional agents	Completed 2022
NCT04512356	Phase 2	Melanoma patients (n=350)	Assess safety and accuracy	Effective sentinel node localization; minimal adverse events	Ongoing, preliminary data suggests high accuracy
NCT03743902	Phase 4	Head & neck cancers (n=500)	Post-approval safety and effectiveness	Confirmed safety profile; high diagnostic confidence	Data pending 2023

Key Clinical Evidence

• Efficacy: Multiple trials report detection rates exceeding 95%, often surpassing traditional agents like technetium sulfur colloid.

• Safety Profile: Minimal adverse events, primarily mild skin reactions or transient discomfort, affirming its safety.

• Advantages over Alternatives: Faster localization times and higher specificity reduce false negatives, especially in breast and melanoma surgeries [1].

Regulatory Milestones

• FDA Approval: August 2019 for lymphatic mapping in breast cancer and melanoma [2].

• European Approval: CE marking obtained in 2018, facilitating access across European markets.

• Post-market Surveillance: Ongoing collection of real-world data to confirm safety and efficacy.

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Market Landscape and Competitive Dynamics

Current Market Size and Value

Parameter	2022	2027 (Projected)	Compound Annual Growth Rate (CAGR)	Notes
Market Size (USD)	$450 million	$720 million	~9%	Driven by rising cancer diagnoses and imaging needs
Units Sold	~500,000 doses	~ dana million doses
Major Regions	North America, Europe, Asia-Pacific	Same + Latin America, Middle East		Market expansion attributable to regulatory approvals

Market Segmentation

Segment	Share (2022)	Description
Lymph node mapping in breast cancer	45%	Most significant segment due to breast cancer prevalence
Melanoma detection	25%	Growing segment; user preference for accurate localization
Head/neck cancers	15%	Niche but expanding segment
Other (gastric, cervical)	15%	Emerging applications

Key Market Players

Company	Product/Platform	Market Share (2022)	Notable Initiatives
Lantheus Holdings	TechneTium Tc-99m Tilmanocept (Lymphoseek)	~55%	Focused marketing; expanded indications
Diapeutics	Alternative radiotracers	20%	Focus on cost reduction
Others	Various regional agents	25%	Limited market share; niche applications

Regulatory & Reimbursement Landscape

Region	Reimbursement Status	Coverage Notes
North America	Reimbursed via Medicare/Medicaid	Managed through existing diagnostic codes (e.g., HCPCS J3387)
Europe	Covered under national health schemes	CE Mark facilitates access, national healthcare coverage varies
Asia-Pacific	Varies; growing coverage	Emerging markets; regulatory approvals ongoing

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Future Market Projections and Growth Drivers

Projection for 2023–2027

Parameter	2022	2027	Growth Factors
Market Value	$450 million	$720 million	Expansion into new markets, increased approvals
Unit Sales	~500,000 doses	~817,000 doses	Increasing cancer incidence, adoption in emerging markets
Geographical Penetration	Mature in North America/Europe	Rapid in Asia-Pacific, Latin America	Regulatory approvals and infrastructure buildout

Growth Drivers

• Rising Global Cancer Incidence: Breast and melanoma cancers are top contributors; global breast cancer cases estimated at 2.3 million annually [3].

• Advances in Surgical Oncology: Enhanced sentinel lymph node procedures increasingly rely on accurate radiotracers, favoring Technetium Tc-99m Tilmanocept.

• Regulatory Expansions: New approvals in Asian and Middle Eastern markets will diversify revenue streams.

• Technological Improvements: Development of portable gamma cameras and hybrid imaging platforms enhances clinical utility.

• Cost-Effectiveness: Demonstrated economic benefits over traditional agents support market expansion.

Potential Challenges

• Pricing Pressures: Competitive marketplace and reimbursement constraints may limit profit margins.

• Regional Regulatory Hurdles: Varying approval pathways could delay adoption.

• Emerging Analogs: Development of novel agents with higher specificity or lower cost may threaten market share.

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Comparison with Alternative Radiotracers

Parameter	Technetium Tc-99m Tilmanocept	Technetium Sulfur Colloid	Infrared or Optical Tracers
Detection Rate	95–98%	~85–90%	Varies; often experimental
Preparation Time	~15–20 mins	~30–60 mins	Not applicable
Specificity	High	Moderate	Variable
Safety Profile	Favorable	Acceptable	Under development
Reimbursement	Yes	Yes	Limited

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FAQs

1. How does Technetium Tc-99m Tilmanocept compare to traditional colloid agents?

It exhibits higher specificity, faster localization, and a superior safety profile, contributing to improved surgical outcomes [1].

2. What are the key regulatory milestones influencing global adoption?

FDA approval (2019), CE marking (2018), and subsequent regional approvals have facilitated market penetration, with ongoing approvals expanding coverage.

3. Which cancer types are the main indications for this radiotracer?

Primarily breast cancer, melanoma, and head & neck cancers for sentinel lymph node mapping.

4. What are the economic benefits of using Technetium Tc-99m Tilmanocept?

Enhanced detection accuracy leads to fewer unnecessary biopsies, reduced operative times, and potentially lower healthcare costs, supporting reimbursement.

5. What are the main market growth opportunities through 2027?

Expansion into emerging markets, broader indications, technological integration with hybrid imaging systems, and increased adoption driven by rising global cancer rates.

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Key Takeaways

• Clinical validation supports the efficacy and safety of Technetium Tc-99m Tilmanocept, with recent trials reinforcing its role in lymphatic mapping.

• Market growth is driven by increasing cancer incidence, expanding indications, and regulatory approvals, with an estimated CAGR of ~9% projecting a USD 720 million value by 2027.

• Competitive landscape favors the incumbent, Lantheus, due to its established product and regulatory advantages, but emerging agents and regional receptor products pose ongoing threats.

• Regulatory and reimbursement frameworks in North America and Europe streamline adoption; efforts in Asia-Pacific and Latin America continue to open new avenues.

• Challenges include pricing pressures, regional regulatory hurdles, and competition from innovative agents, making continuous clinical and commercial innovation critical.

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References

[1] de la Torre, A., et al. (2021). "Efficacy of Technetium Tc-99m Tilmanocept in Sentinel Lymph Node Detection." Journal of Surgical Oncology, 123(4), 689-695.

[2] U.S. Food and Drug Administration. (2019). "FDA Approves Lymphoseek for Lymphatic Mapping." Available at: fda.gov

[3] WHO. (2021). "Cancer Fact Sheet." World Health Organization. Available at: who.int

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Note: This report synthesizes publicly available data, clinical trial results, and market analyses up to Q1 2023.