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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR ISOSULFAN BLUE


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All Clinical Trials for Isosulfan Blue

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003186 ↗ Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer Completed National Cancer Institute (NCI) N/A 1997-04-01 RATIONALE: Diagnostic procedures, such as lymphography, may improve the identification of patients with metastatic colorectal cancer. PURPOSE: Clinical trial to study the effectiveness of lymphography in determining the presence or absence of metastatic colorectal cancer in patients.
NCT00003186 ↗ Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer Completed Roswell Park Cancer Institute N/A 1997-04-01 RATIONALE: Diagnostic procedures, such as lymphography, may improve the identification of patients with metastatic colorectal cancer. PURPOSE: Clinical trial to study the effectiveness of lymphography in determining the presence or absence of metastatic colorectal cancer in patients.
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.
NCT00012168 ↗ Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat Completed NYU Langone Health 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.
NCT00070317 ↗ Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer Terminated National Cancer Institute (NCI) N/A 2004-06-01 This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Isosulfan Blue

Condition Name

Condition Name for Isosulfan Blue
Intervention Trials
Breast Cancer 5
Colorectal Cancer 2
Stage IIC Melanoma 1
Breast Cancer Stage II 1
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Condition MeSH

Condition MeSH for Isosulfan Blue
Intervention Trials
Breast Neoplasms 6
Lymphedema 3
Melanoma 3
Colorectal Neoplasms 2
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Clinical Trial Locations for Isosulfan Blue

Trials by Country

Trials by Country for Isosulfan Blue
Location Trials
United States 36
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Trials by US State

Trials by US State for Isosulfan Blue
Location Trials
California 4
Pennsylvania 3
New York 3
Ohio 3
Florida 2
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Clinical Trial Progress for Isosulfan Blue

Clinical Trial Phase

Clinical Trial Phase for Isosulfan Blue
Clinical Trial Phase Trials
Phase 3 1
Phase 2 2
Phase 1/Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Isosulfan Blue
Clinical Trial Phase Trials
Completed 9
Terminated 3
Not yet recruiting 1
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Clinical Trial Sponsors for Isosulfan Blue

Sponsor Name

Sponsor Name for Isosulfan Blue
Sponsor Trials
National Cancer Institute (NCI) 10
Stanford University 2
City of Hope Medical Center 1
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Sponsor Type

Sponsor Type for Isosulfan Blue
Sponsor Trials
Other 17
NIH 11
Industry 1
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Isosulfan Blue: Clinical Trials, Market Analysis, and Projections

Introduction

Isosulfan blue, a triphenylmethane dye, has been a cornerstone in medical diagnostics, particularly in sentinel lymph node mapping and lymphography. Here, we delve into the clinical trials, market analysis, and future projections for this vital medical dye.

Clinical Use and Indications

Isosulfan blue is primarily used for sentinel lymph node (SLN) mapping, a procedure crucial in the diagnosis and treatment of various cancers, including breast cancer, melanoma, and other malignancies. It is administered subcutaneously and helps in identifying the lymphatic vessels and nodes involved in the drainage of the tumor site[4].

Clinical Trials and Efficacy

Numerous studies have highlighted the efficacy of isosulfan blue in SLN mapping. For instance, a study involving 543 patients showed that isosulfan blue was effective in identifying sentinel lymph nodes with a low incidence of allergic reactions, which were generally mild and transient[4].

Another study published in Drug Development and Industrial Pharmacy emphasized the quick localization and precise biopsy of sentinel lymph nodes using isosulfan blue, making it a preferred choice in breast cancer diagnostics in Europe and the United States[1].

Safety Profile

While isosulfan blue is generally safe, it is not without risks. Hypersensitivity reactions, including life-threatening anaphylaxis, can occur in approximately 2% of patients. These reactions are more likely in individuals with a history of allergies or previous reactions to triphenylmethane dyes. Monitoring patients for at least 60 minutes after administration is recommended, and trained personnel should be available for emergency care[4].

Market Analysis

Current Market Scenario

The market for isosulfan blue is stable, driven by its established use in sentinel lymph node mapping and other lymphographic procedures. It is the only FDA-approved blue dye for this purpose, which contributes to its market dominance[4].

Market Drivers

  • Demand in Oncology: The increasing incidence of cancers, particularly breast cancer and melanoma, drives the demand for accurate diagnostic tools like isosulfan blue.
  • Clinical Efficacy: The dye's high efficacy in identifying sentinel lymph nodes without significant side effects supports its continued use.
  • Regulatory Approval: Being the only FDA-approved blue dye for SLN mapping ensures its market position[4].

Market Restraints

  • Allergic Reactions: The risk of hypersensitivity reactions, although low, can be a deterrent for some patients and healthcare providers.
  • Alternative Dyes: Methylene blue, though less preferred due to its higher risk of anaphylaxis and poorer targeting of sentinel nodes, remains an alternative, potentially affecting market share[1][2].

Market Projections

Future Growth

The market for isosulfan blue is expected to grow steadily, driven by the increasing need for precise cancer diagnostics. Here are some key projections:

  • Increasing Cancer Incidence: As the global population ages and cancer incidence rises, the demand for diagnostic tools like isosulfan blue will increase.
  • Technological Advancements: Improvements in lymphography and SLN mapping techniques will further solidify the position of isosulfan blue in the market.
  • Regulatory Stability: Continued FDA approval and lack of significant competition from other dyes will maintain its market dominance[4].

Market Size and Share

The exact market size and share of isosulfan blue are not readily available, but it is clear that it holds a significant position in the diagnostic dye market due to its specific indications and FDA approval.

Competitive Landscape

Isosulfan blue faces competition from methylene blue, although the latter has several drawbacks, including higher rates of anaphylaxis and poorer absorption characteristics. The lack of other FDA-approved alternatives for SLN mapping ensures that isosulfan blue remains a leading choice[1][2].

Conclusion

Isosulfan blue is a critical tool in modern oncology, particularly in the identification of sentinel lymph nodes. Its efficacy, safety profile, and regulatory approval make it a staple in diagnostic procedures. While it faces some competition from methylene blue, its unique advantages and established market position ensure its continued relevance.

Key Takeaways

  • Efficacy in SLN Mapping: Isosulfan blue is highly effective in identifying sentinel lymph nodes.
  • Safety Profile: It has a low incidence of allergic reactions, although monitoring is necessary.
  • Market Dominance: It is the only FDA-approved blue dye for SLN mapping.
  • Future Growth: The market is expected to grow due to increasing cancer incidence and technological advancements.
  • Regulatory Stability: Continued FDA approval supports its market position.

FAQs

Q: What is the primary use of isosulfan blue in medical diagnostics?

A: Isosulfan blue is primarily used for sentinel lymph node (SLN) mapping in various types of cancer.

Q: What are the common side effects of isosulfan blue?

A: Common side effects include hypersensitivity reactions, transient or long-term blue coloration of the skin, and interference with pulse oximetry readings.

Q: Is isosulfan blue FDA-approved?

A: Yes, isosulfan blue is FDA-approved for sentinel lymph node mapping and other lymphographic procedures.

Q: How does isosulfan blue compare to methylene blue in terms of efficacy and safety?

A: Isosulfan blue has better targeting of sentinel nodes and a lower risk of allergic reactions compared to methylene blue, although methylene blue is cheaper and more readily available[1].

Q: What are the market drivers for isosulfan blue?

A: The market is driven by the increasing incidence of cancers, its clinical efficacy, and its regulatory approval.

Sources

  1. Taylor & Francis: Isosulfan blue – Knowledge and References.
  2. Allied Market Research: Methylene Blue Market Size, Share | Industry Growth & Forecast 2027.
  3. The Lancet: Pharmacotherapy of obesity: an update on the available data.
  4. Mylan: Isosulfan Blue Injection 1%.
  5. University of Maryland: Sulfan Blue.

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