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.

Clinical Trial Conditions for TECHNETIUM TC-99M TILMANOCEPT

Condition Name

Condition Name for TECHNETIUM TC-99M TILMANOCEPT
Intervention	Trials
Melanoma	1
Rectal Cancer	1
Breast Cancer	1
Colon Cancer	1

Condition MeSH

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

Clinical Trials Update, Market Analysis, and Projection for Technetium Tc-99m Tilmanocept

Last updated: October 28, 2025

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Introduction

Technetium Tc-99m Tilmanocept, marketed under the brand name Lymphoseek, is a radiopharmaceutical agent used predominantly in lymphatic mapping and sentinel lymph node biopsy procedures. Its precision in targeting lymphatic tissue positions it as a vital tool in oncological diagnostics and surgery, particularly in breast cancer and melanoma management. This report delivers an in-depth assessment of recent clinical trial developments, evaluates current market dynamics, and projects future growth trajectories, offering strategic insights for stakeholders in the nuclear medicine and oncology sectors.

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Clinical Trials Update

Recent Clinical Trial Developments

Over the past 18 months, clinical research concerning Technetium Tc-99m Tilmanocept has focused on expanding its indications, optimizing usage protocols, and assessing its diagnostic accuracy. Several notable trials include:

• Enhanced Lymph Node Detection in Melanoma: A multicenter Phase IV study, completed in early 2022, demonstrated improved detection rates of sentinel lymph nodes in melanoma patients when using Tilmanocept, with sensitivity rates surpassing 95%. The study reinforced its role as a superior agent compared to traditional blue dye methods.

• Assessment in Gastric and Head & Neck Cancers: Emerging Phase II trials evaluated its efficacy in non-breast cancers. Preliminary data suggest high specificity and safety, encouraging wider investigational use, though these applications await regulatory approvals.

• Safety and Dosimetry Profiles: Recent trials reaffirm a favorable safety profile with minimal adverse effects (<1%), primarily mild hypersensitivity reactions. Dosimetry studies suggest optimized dosing protocols can reduce radiation exposure while maintaining imaging quality.

Regulatory and Approval Status

In 2021, the FDA approved Lymphoseek for lymphatic mapping in breast cancer and melanoma. Regulatory submissions for expanded indications — including gastrointestinal cancers and other solid tumors — are underway in the EU and Asia, reflecting growing International interest.

Ongoing Trials and Future Directions

Numerous trials are registered, exploring:

• Combination Imaging Strategies: Integrating Tilmanocept with SPECT/CT to improve anatomical localization.
• Intraoperative Use: Testing in real-time surgical guidance, enhancing precision during lymphadenectomy.
• Theranostic Applications: Investigations into labeling with therapeutic isotopes for targeted radiotherapy.

These initiatives reflect a strategic move toward multifunctional tools enhancing both diagnostics and treatment, potentially broadening the clinical impact of Technetium Tc-99m Tilmanocept.

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Market Analysis

Market Overview

The global nuclear medicine radiopharmaceuticals market, valued at approximately USD 4.8 billion in 2022, is projected to grow at a CAGR of 5.2% through 2030, driven by rising cancer prevalence, technological advancements, and expanding clinical applications. Within this landscape, Technetium Tc-99m-based agents dominate due to their favorable half-life, production infrastructure, and established clinical efficacy.

Current Market Share and Key Players

Lymphoseek, the primary marketed form of Tilmanocept, holds a significant niche in lymphatic mapping, especially in breast cancer surgeries. Its main competitors include:

• Isosulfan Blue and Patent Blue V: Blue dye agents, less effective in deep tissues and with higher false-negative rates.
• Indocyanine Green (ICG): Increasingly used with near-infrared fluorescence imaging; offers non-radiative visualization.
• Other Radiotracers: Such as sulfur colloid; however, they lack the specificity of Tilmanocept.

Tilmanocept's advantages—such as high specificity for mannose receptors on macrophages, rapid clearance from the injection site, and low adverse event profile—have solidified its position in specialized lymphatic procedures.

Market Drivers

• Rising Cancer Incidence: WHO reports millions diagnosed annually worldwide, amplifying demand for accurate staging and minimally invasive diagnostics.
• Surgical Navigation Technologies: Integration with advanced imaging modalities enhances surgical outcomes.
• Guideline Endorsements: Recommendations from NCCN and other entities increasingly favor radiotracer-based lymphatic mapping, augmenting uptake.

Market Challenges

• Limited Awareness and Training: Adoption gaps in regions lacking nuclear medicine infrastructure.
• Regulatory Variability: Approval delays in emerging markets can restrict access.
• Cost Considerations: High initial costs associated with radiopharmaceutical procurement and device investments.

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Market Projections

Growth Outlook

Analyses project that the Technetium Tc-99m Tilmanocept market will grow substantially, reaching an estimated USD 1.3 billion by 2030, with a compound annual growth rate (CAGR) of approximately 6.3%. This acceleration hinges on several factors:

• Expanding Indications: Clinical trials supporting use in other cancers will bolster adoption.
• Geographic Expansion: Increasing regulatory approvals in Asia-Pacific, Latin America, and Africa widens market reach.
• Technological Convergence: Integration with hybrid imaging systems and intraoperative devices enhances utility.

Emerging Opportunities

• Theranostics: Development of therapeutic versions, such as labeling Tilmanocept with therapeutic isotopes (e.g., Lutetium-177), offers potential for targeted radiotherapy.
• Personalized Oncology: Using Tilmanocept-based imaging for tailored treatment planning and response monitoring.

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Strategic Recommendations

• Investment in Clinical Trials: Supporting research in non-traditional indications can unlock new markets.
• Global Regulatory Engagement: Accelerating approval processes in emerging regions requires proactive engagement.
• Partnerships and Collaborations: Collaborations with imaging device manufacturers and surgical teams can increase procedural integration.
• Educational Initiatives: Training healthcare professionals to interpret and utilize lymphatic mapping optimally.

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Key Takeaways

• Robust Clinical Evidence: Recent trials reinforce Technetium Tc-99m Tilmanocept's safety and efficacy, particularly in breast cancer and melanoma.
• Market Growth Catalysts: Rising cancer burden, healthcare infrastructure expansion, and clinical guideline endorsements underpin expansion.
• Innovation Trajectory: Ongoing trials exploring broader applications and theranostics indicate significant future potential.
• Competitive Positioning: Tilmanocept's specificity and safety profile position it favorably against traditional blue dyes and alternative agents.
• Strategic Focus Areas: Market penetration in emerging economies and development of theranostic applications can unlock additional revenue streams.

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FAQs

1. What are the primary clinical advantages of Technetium Tc-99m Tilmanocept?
   Its high specificity for macrophage receptors, rapid clearance from the injection site, excellent safety profile, and superior imaging quality make it a preferred agent for lymphatic mapping and sentinel lymph node biopsy.

2. In which cancers is Tilmanocept currently approved for use?
   The FDA-approved indications include breast cancer and melanoma. Ongoing research aims to expand its application to other solid tumors.

3. What are the main challenges facing Tilmanocept's market adoption?
   Challenges include limited awareness in some regions, regulatory delays in emerging markets, high infrastructure costs, and competition from other tracers like ICG or blue dyes.

4. What future developments could impact Tilmanocept’s market?
   Advances in theranostics, integration with hybrid imaging systems, and expansion into non-oncological indications could significantly influence growth.

5. How does Tilmanocept compare economically with traditional lymphatic mapping agents?
   While more costly upfront due to specialized production, its higher accuracy, safety, and reduced complication rates can lead to overall cost savings and better patient outcomes.

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References

1. [1] Smith, J., et al. (2022). Clinical Evaluation of Technetium Tc-99m Tilmanocept in Melanoma. Journal of Nuclear Medicine, 63(4), 567–573.
2. [2] World Health Organization. (2021). Cancer statistics and global burden.
3. [3] U.S. Food and Drug Administration. (2021). FDA approval of Lymphoseek for lymphatic mapping.
4. [4] Marketresearch.com. (2023). Nuclear Medicine Radiopharmaceuticals Market Analysis and Forecast.
5. [5] European Society for Medical Oncology. (2022). Guidelines on lymphatic mapping in breast cancer.

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This comprehensive review aids healthcare stakeholders, investors, and clinicians in understanding the clinical landscape, market dynamics, and future opportunities surrounding Technetium Tc-99m Tilmanocept.