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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR LYMPHAZURIN


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All Clinical Trials for Lymphazurin

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00070317 ↗ Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer Terminated Gynecologic Oncology Group 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.
NCT00438477 ↗ Injection Methods in Finding the Sentinel Lymph Node During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Invasive Breast Cancer Completed National Cancer Institute (NCI) N/A 2005-06-01 RATIONALE: Diagnostic procedures, such as lymphoscintigraphy using an injection under the nipple or near the tumor, may help doctors find out how far the disease has spread. PURPOSE: This clinical trial is studying two different injection methods to compare how well they find the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in patients with invasive breast cancer.
NCT00438477 ↗ Injection Methods in Finding the Sentinel Lymph Node During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Invasive Breast Cancer Completed M.D. Anderson Cancer Center N/A 2005-06-01 RATIONALE: Diagnostic procedures, such as lymphoscintigraphy using an injection under the nipple or near the tumor, may help doctors find out how far the disease has spread. PURPOSE: This clinical trial is studying two different injection methods to compare how well they find the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in patients with invasive breast cancer.
NCT00450723 ↗ Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer Completed University of Miami N/A 2004-05-01 RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment. PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.
NCT00450723 ↗ Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer Completed University of Miami Sylvester Comprehensive Cancer Center N/A 2004-05-01 RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment. PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lymphazurin

Condition Name

Condition Name for Lymphazurin
Intervention Trials
Breast Cancer 3
Endometrial Cancer 2
Cervical Adenocarcinoma 1
Stage II Endometrial Carcinoma 1
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Condition MeSH

Condition MeSH for Lymphazurin
Intervention Trials
Melanoma 3
Breast Neoplasms 3
Endometrial Neoplasms 3
Carcinoma 2
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Clinical Trial Locations for Lymphazurin

Trials by Country

Trials by Country for Lymphazurin
Location Trials
United States 14
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Trials by US State

Trials by US State for Lymphazurin
Location Trials
Ohio 3
California 3
Texas 2
Pennsylvania 2
Florida 2
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Clinical Trial Progress for Lymphazurin

Clinical Trial Phase

Clinical Trial Phase for Lymphazurin
Clinical Trial Phase Trials
Phase 2 2
Phase 1/Phase 2 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Lymphazurin
Clinical Trial Phase Trials
Completed 7
Terminated 3
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Clinical Trial Sponsors for Lymphazurin

Sponsor Name

Sponsor Name for Lymphazurin
Sponsor Trials
National Cancer Institute (NCI) 4
Stanford University 2
Cardinal Health 414, LLC 2
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Sponsor Type

Sponsor Type for Lymphazurin
Sponsor Trials
Other 10
NIH 4
Industry 4
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Lymphazurin: Current Clinical Trials, Market Analysis, and Projections

Introduction to Lymphazurin

Lymphazurin, also known as isosulfan blue, is a vital blue dye used for sentinel lymph node (SLN) mapping in various cancers. It has been the gold standard for this procedure due to its simplicity of use and high accuracy in identifying lymphatic channels.

Clinical Trials and Comparative Studies

Sentinel Lymph Node Mapping in Colorectal Tumors

A prospective study compared the efficacy of 1% Lymphazurin and 10% fluorescein for SLN mapping in colorectal tumors. The study found that both dyes had high success rates for mapping, with Lymphazurin achieving a 99% success rate and fluorescein a 97% success rate. The accuracy of predicting nodal metastases was 95.8% for Lymphazurin and 93.1% for fluorescein, with no statistically significant differences between the two dyes except for cost[1].

Comparison with Methylene Blue in Breast Cancer

Another study compared Lymphazurin with methylene blue for SLN mapping in breast cancer patients. The results indicated that methylene blue was equivalent to Lymphazurin in terms of success rates, nodes identified per case, and technique used for node identification. This suggests that methylene blue could be a viable alternative when Lymphazurin is unavailable[2].

Use in Pediatric Patients

A Phase 2 study evaluated the safety and tolerability of Lymphoseek, a radioactive tracing agent, in comparison with Lymphazurin in pediatric patients with melanoma, rhabdomyosarcoma, or other solid tumors. The study aimed to assess the concordance of in vivo localization rates between Lymphoseek and Lymphazurin. While the primary focus was on Lymphoseek, the study highlighted the ongoing use and comparison of Lymphazurin in various clinical settings[4].

Market Analysis

Current Market Position

Lymphazurin remains the gold standard for SLN mapping due to its high accuracy and ease of use. However, its higher cost compared to alternatives like fluorescein and methylene blue can be a significant factor in healthcare settings where budget constraints are a concern. The cost of Lymphazurin is $99.00 per vial, whereas fluorescein costs $2.10 per vial[1].

Competitive Landscape

The market for SLN mapping agents is evolving with the introduction of new agents like Lymphoseek. Lymphoseek, a radioactive tracing agent, is being evaluated for its safety and efficacy in pediatric patients and shows promise in terms of localization rates and safety profiles. However, Lymphazurin's established reputation and widespread use make it a dominant player in the market[4].

Future Projections

Given the ongoing clinical trials and comparisons with other agents, Lymphazurin is likely to maintain its position as a preferred agent for SLN mapping. However, the availability and lower cost of alternatives like fluorescein and methylene blue may increase their adoption in certain clinical settings.

Emerging Trends

The oncology market is witnessing significant advancements, including the development of new therapies and diagnostic tools. While these trends do not directly impact Lymphazurin's use, they highlight the evolving landscape of cancer treatment and diagnosis. For instance, the use of radioactive tracing agents like Lymphoseek could become more prevalent, potentially influencing the market share of traditional dyes like Lymphazurin[5].

Safety and Efficacy

Safety Profile

Studies have consistently shown that Lymphazurin has a favorable safety profile. There were no adverse reactions observed in the comparative study with fluorescein, and similar safety outcomes have been reported in other studies[1][2].

Efficacy in Various Cancers

Lymphazurin has been used effectively in various types of cancers, including breast cancer, colorectal tumors, and melanoma. Its ability to accurately identify sentinel lymph nodes is crucial for staging and treatment planning. The accuracy rates for predicting nodal metastases have been high across different studies, reinforcing its efficacy[1][2].

Cost Considerations

The cost of Lymphazurin is a significant factor in its adoption. At $99.00 per vial, it is substantially more expensive than alternatives like fluorescein. However, its proven efficacy and ease of use justify the cost in many clinical settings[1].

Regulatory Status

Lymphazurin was the first dye to be approved by the Food and Drug Administration (FDA) for the localization of lymphatic channels. Its regulatory status remains unchanged, and it continues to be widely used under FDA approval[1].

Key Takeaways

  • Clinical Efficacy: Lymphazurin remains highly effective for SLN mapping across various cancers.
  • Safety Profile: It has a favorable safety profile with no significant adverse reactions reported.
  • Cost: Despite its higher cost, Lymphazurin's efficacy and ease of use make it a preferred choice.
  • Market Position: It is the gold standard, but alternatives like fluorescein and methylene blue are gaining traction due to lower costs.
  • Future Trends: The market may see increased use of radioactive tracing agents, but Lymphazurin is likely to maintain its dominance.

FAQs

What is Lymphazurin used for?

Lymphazurin is used for sentinel lymph node (SLN) mapping in various cancers to identify the first lymph node to which cancer cells are likely to spread.

How does Lymphazurin compare to other dyes like fluorescein?

Lymphazurin and fluorescein have similar success rates and accuracy for SLN mapping, but Lymphazurin is more expensive. However, Lymphazurin remains the gold standard due to its ease of use and high accuracy.

Is Lymphazurin safe to use?

Yes, Lymphazurin has a favorable safety profile with no significant adverse reactions reported in clinical studies.

What are the cost implications of using Lymphazurin?

Lymphazurin is significantly more expensive than alternatives like fluorescein, costing $99.00 per vial compared to $2.10 per vial for fluorescein.

Are there any emerging alternatives to Lymphazurin?

Yes, radioactive tracing agents like Lymphoseek are being evaluated and show promise in terms of safety and efficacy, potentially influencing the market share of traditional dyes like Lymphazurin.

Sources

  1. JAMA Surgery: "1% Lymphazurin vs 10% Fluorescein for Sentinel Node Mapping in Colorectal Tumors"[1]
  2. PubMed: "A comparison of methylene blue and lymphazurin in breast cancer"[2]
  3. ClinicalTrials.gov: "A Prospective, Open-Label, Multicenter Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors"[4]
  4. Blue Matter Consulting: "The Oncology Market: 2023 Year in Review"[5]

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