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Last Updated: March 7, 2025

CLINICAL TRIALS PROFILE FOR TECHNETIUM TC-99M SULFUR COLLOID


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All Clinical Trials for Technetium Tc-99m Sulfur Colloid

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003654 ↗ Diagnostic Study to Identify Sentinel Lymph Nodes in Women With Stage I or Stage II Breast Cancer Terminated UNICANCER N/A 1997-09-01 RATIONALE: Diagnostic procedures, such as blue dye or imaging to identify sentinel lymph nodes, may improve the ability to detect the extent of disease and help plan effective surgery for removing breast tumors. PURPOSE: Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to identify the sentinel lymph node under the arm in women with stage I or stage II breast cancer.
NCT00012168 ↗ Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat Completed National Cancer Institute (NCI) N/A 1999-05-01 RATIONALE: New imaging procedures such as lymphoscintigraphy may improve the ability to detect the spread of mouth and throat cancer to lymph nodes in the neck. PURPOSE: Pilot study of lymphoscintigraphy followed by sentinel lymph node mapping and sentinel lymph node biopsy to detect lymph node metastases in the neck in patients who have mouth or throat cancer.
NCT00012168 ↗ Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat Completed New York University School of Medicine N/A 1999-05-01 RATIONALE: New imaging procedures such as lymphoscintigraphy may improve the ability to detect the spread of mouth and throat cancer to lymph nodes in the neck. PURPOSE: Pilot study of lymphoscintigraphy followed by sentinel lymph node mapping and sentinel lymph node biopsy to detect lymph node metastases in the neck in patients who have mouth or throat cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Technetium Tc-99m Sulfur Colloid

Condition Name

Condition Name for Technetium Tc-99m Sulfur Colloid
Intervention Trials
Breast Cancer 6
Stage II Breast Cancer 2
Cystic Fibrosis 2
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Condition MeSH

Condition MeSH for Technetium Tc-99m Sulfur Colloid
Intervention Trials
Breast Neoplasms 8
Fibrosis 2
Cystic Fibrosis 2
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Clinical Trial Locations for Technetium Tc-99m Sulfur Colloid

Trials by Country

Trials by Country for Technetium Tc-99m Sulfur Colloid
Location Trials
United States 17
France 2
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Trials by US State

Trials by US State for Technetium Tc-99m Sulfur Colloid
Location Trials
Pennsylvania 3
California 3
Texas 2
New York 2
Minnesota 1
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Clinical Trial Progress for Technetium Tc-99m Sulfur Colloid

Clinical Trial Phase

Clinical Trial Phase for Technetium Tc-99m Sulfur Colloid
Clinical Trial Phase Trials
Phase 2 2
Phase 1/Phase 2 1
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Technetium Tc-99m Sulfur Colloid
Clinical Trial Phase Trials
Completed 12
Recruiting 3
Terminated 3
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Clinical Trial Sponsors for Technetium Tc-99m Sulfur Colloid

Sponsor Name

Sponsor Name for Technetium Tc-99m Sulfur Colloid
Sponsor Trials
National Cancer Institute (NCI) 9
University of Pittsburgh 2
M.D. Anderson Cancer Center 2
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Sponsor Type

Sponsor Type for Technetium Tc-99m Sulfur Colloid
Sponsor Trials
Other 25
NIH 12
Industry 3
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Technetium Tc-99m Sulfur Colloid: Clinical Trials, Market Analysis, and Projections

Introduction

Technetium Tc-99m Sulfur Colloid is a versatile radioactive diagnostic agent widely used in various medical imaging procedures. This article will delve into the clinical trials, market analysis, and future projections for this important radiopharmaceutical.

Clinical Indications and Usage

Technetium Tc-99m Sulfur Colloid is indicated for several critical diagnostic purposes:

  • Localization of Lymph Nodes: In adults, it helps in identifying lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma, often used in conjunction with a hand-held gamma counter[1][4][5].
  • Evaluation of Peritoneo-Venous Shunt Patency: It is used to assess the functionality of LeVeen shunts in adults[1][5].
  • Imaging of Reticuloendothelial Cells: It is employed to image areas of functioning reticuloendothelial cells in the liver, spleen, and bone marrow in both adults and pediatric patients[1][4][5].
  • Gastroesophageal Studies: It aids in the evaluation of esophageal transit, gastroesophageal reflux, and the detection of pulmonary aspiration of gastric contents[1][4][5].

Clinical Trials and Efficacy

Clinical trials have demonstrated the efficacy of Technetium Tc-99m Sulfur Colloid in various applications:

  • Lymphoscintigraphy: Studies have shown that the colloid's particle size is crucial for its effectiveness. Filtered Technetium-99m Sulfur Colloid, with particles primarily in the 15-50 nm range, has been found to be highly effective in lymphoscintigraphic studies, offering faster transport rates to lymph nodes and lower radiation dosimetry compared to other formulations[2].
  • Comparative Studies: Clinical studies have compared the performance of Technetium Tc-99m Sulfur Colloid with other radiopharmaceuticals, such as Technetium-99m Antimony Sulfide Colloid, and found similar or superior outcomes in terms of lymph node visualization and radiation safety[2].

Market Analysis

The market for Technetium Tc-99m Sulfur Colloid is part of the broader Technetium-99m market, which is experiencing significant growth:

  • Market Size and Growth: The Technetium-99m market was valued at USD 4.95 billion in 2023 and is expected to grow at a CAGR of 4.05% up to 2030. This growth is driven by the increasing demand for Tc-99m-based radiopharmaceuticals in cardiovascular imaging, cancer detection, and other clinical applications[3].
  • Geographical Dominance: North America, particularly the United States and Canada, leads the global market due to advanced healthcare infrastructure, high prevalence of chronic diseases, and significant investments in medical imaging technology. The U.S. alone conducts over 40,000 Tc-99m-based imaging procedures daily[3].

Market Segmentation

The Technetium-99m market, including Technetium Tc-99m Sulfur Colloid, is segmented based on various applications:

  • Cardiovascular Imaging: This segment holds the largest market share, primarily due to its critical role in myocardial perfusion imaging, which assesses blood flow in the heart[3].
  • Cancer Detection: Technetium Tc-99m Sulfur Colloid is used in detecting lymph node metastases in breast cancer and malignant melanoma, contributing to the market growth in oncology applications[1][4][5].
  • Other Clinical Applications: It is also used in imaging the liver, spleen, bone marrow, and in studies of esophageal transit and gastroesophageal reflux, further diversifying its market presence[1][4][5].

Future Projections

Several factors are expected to drive the future growth of the Technetium Tc-99m Sulfur Colloid market:

  • Advancements in Radiopharmaceuticals: Ongoing research and development are focused on creating new Tc-99m-based radiopharmaceuticals with improved specificity and sensitivity. These advancements will expand the utility of Tc-99m in various clinical applications, including cancer, cardiovascular disease, and neurological disorders[3].
  • Increasing Diagnostic Procedures: The growing number of diagnostic procedures using Tc-99m, driven by the need for more accurate and early disease detection, will continue to fuel market growth. In the U.S., for example, there are over 20 million nuclear medicine procedures annually, with a significant portion using Tc-99m[3].

Key Takeaways

  • Versatile Diagnostic Agent: Technetium Tc-99m Sulfur Colloid is used in a variety of diagnostic imaging procedures, including lymph node localization, shunt patency evaluation, and imaging of reticuloendothelial cells.
  • Clinical Efficacy: Clinical trials have demonstrated its effectiveness, particularly in lymphoscintigraphy, with favorable particle size and lower radiation dosimetry.
  • Market Growth: The market is driven by increasing demand in cardiovascular imaging, cancer detection, and other clinical applications, with North America leading the global market.
  • Future Prospects: Advancements in radiopharmaceuticals and the growing number of diagnostic procedures will continue to drive market growth.

FAQs

What are the primary indications for Technetium Tc-99m Sulfur Colloid?

Technetium Tc-99m Sulfur Colloid is primarily indicated for the localization of lymph nodes draining a primary tumor in breast cancer or malignant melanoma, evaluation of peritoneo-venous shunt patency, imaging of reticuloendothelial cells in the liver, spleen, and bone marrow, and studies of esophageal transit and gastroesophageal reflux[1][4][5].

How is Technetium Tc-99m Sulfur Colloid administered?

The administration of Technetium Tc-99m Sulfur Colloid varies by application, including subcutaneous injection for lymph node localization, intravenous injection for imaging reticuloendothelial cells, and oral administration for gastroesophageal studies[1].

What are the key advantages of Technetium Tc-99m Sulfur Colloid in clinical use?

The key advantages include its optimal particle size for lymphoscintigraphy, lower radiation dosimetry, and its versatility in various diagnostic imaging procedures. It also has a favorable half-life of 6 hours, allowing for imaging at a later period[2][4].

What is the current market size and growth projection for Technetium-99m-based radiopharmaceuticals?

The Technetium-99m market was valued at USD 4.95 billion in 2023 and is expected to grow at a CAGR of 4.05% up to 2030[3].

Which region dominates the global Technetium-99m market?

North America, particularly the United States and Canada, dominates the global market due to advanced healthcare infrastructure and significant investments in medical imaging technology[3].

What are the potential future drivers for the growth of the Technetium Tc-99m Sulfur Colloid market?

Future growth will be driven by advancements in radiopharmaceuticals, increasing diagnostic procedures, and the expanding utility of Tc-99m in various clinical applications[3].

Sources

  1. Drugs.com: Technetium TC 99M Sulfur Colloid: Package Insert / Prescribing Info.
  2. Journal of Nuclear Medicine: Filtered Technetium-99m-Sulfur Colloid Evaluated for Lymphoscintigraphy.
  3. Maximize Market Research: Technetium-99m Market: Industry Analysis and Forecast 2030.
  4. NCBI Bookshelf: Technetium-99m - StatPearls.
  5. DrugBank: Technetium Tc-99m sulfur colloid.

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