CLINICAL TRIALS PROFILE FOR TECHNETIUM TC-99M ALBUMIN KIT

All Clinical Trials for Technetium Tc-99m Albumin Kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005821 ↗	Sentinel Lymph Node Biopsy to Assess Axillary Lymph Nodes in Women With Stage I or Stage II Breast Cancer	Unknown status	Royal Marsden NHS Foundation Trust	Phase 2	1998-12-01	RATIONALE: Diagnostic procedures such as sentinel lymph node biopsy may improve the ability to detect breast cancer and determine the extent of disease. PURPOSE: Phase II trial to study the effectiveness of sentinel lymph node biopsy to assess axillary lymph nodes in women who have stage I or stage II breast cancer.
NCT00847522 ↗	Fluorescein for Lymphatic Mapping and Sentinel Lymph Node (SLN) Biopsy in Patients With Stage I and II Malignant Melanoma	Completed	University of Utah	Phase 1/Phase 2	2009-02-01	The purpose of this research study is to use two different drugs to find where melanoma might spread and to remove these tissues. We believe that tumor cells from the melanoma first move through the lymphatic system (a system of clear fluid that moves around the body and carries white blood cells, much like the blood system) to a lymph node in an orderly way. If we can identify the first lymph nodes to receive a tumor cell, this can be removed and examined. We currently use one drug, called "technetium-99m sulfur colloid" which can detect about 90% of the first lymph nodes that the tumor cells would move to. Technetium-99m is a radioactive compound and can be detected through the skin by a special instrument that reads radioactivity. As part of this research, we would like to use a second drug called "fluorescein" (Fluorescite®) to see if it will identify the same lymph nodes or additional ones and examine these. This drug is fluorescent and can be detected even through the skin using a blue light. This drug is approved by the Federal Drug Administration (FDA) to for injection in the vein as a diagnostic aid and has been safely used in people for many years. In this study, we will be injecting it under the skin, which is a different use from how it is currently approved by the FDA. In the past another drug has been used, called "isosulfan blue" (Lymphazurin®), but availability of this drug is currently limited, and it has higher risks associated with it. This study is being conducted by Dr. Robert Andtbacka, Dr. Dirk Noyes, Dr. James McGreevy and at University of Utah. This study is a Phase I/II and is done to find out if the drug can be used safely when given under the skin and if it will work for this purpose.
NCT01982123 ↗	SPECT/CT in Measuring Lung Function in Patients With Cancer Undergoing Radiation Therapy	Completed	National Cancer Institute (NCI)	N/A	2014-01-17	This pilot clinical trial studies single photon emission computed tomography (SPECT)/computed tomography (CT) in measuring lung function in patients with cancer undergoing radiation therapy. Diagnostic procedures that measure lung function may help doctors find healthy lung tissue and allow them to plan better treatment.
NCT01982123 ↗	SPECT/CT in Measuring Lung Function in Patients With Cancer Undergoing Radiation Therapy	Completed	University of Washington	N/A	2014-01-17	This pilot clinical trial studies single photon emission computed tomography (SPECT)/computed tomography (CT) in measuring lung function in patients with cancer undergoing radiation therapy. Diagnostic procedures that measure lung function may help doctors find healthy lung tissue and allow them to plan better treatment.
NCT02773238 ↗	FLARE RT for Patients With Stage IIB-IIIB Non-small Cell Lung Cancer: Personalizing Radiation Therapy Using PET/CT and SPECT/CT Imaging	Recruiting	National Cancer Institute (NCI)	Phase 2	2016-05-01	This phase II trial studies how well positron emission tomography (PET)/computed tomography (CT) and single positron emission computed tomography (SPECT)/CT imaging works in improving radiation therapy treatment in patients with stage IIB-IIIB non-small cell lung cancer. PET/CT imaging mid-way through treatment may be able to accurately show how well radiation therapy and chemotherapy are working. SPECT/CT imaging may be able to tell which parts of the lung tissue are healthier than others. Based on the result of the imaging, treatment adjustments may be made to the radiation therapy to improve survival and decrease toxicity.

Clinical Trial Conditions for Technetium Tc-99m Albumin Kit

Condition Name

Condition Name for Technetium Tc-99m Albumin Kit
Intervention	Trials
Stage IIIA Non-Small Cell Lung Cancer	1
Stage IIIB Non-Small Cell Lung Cancer	1
Breast Cancer	1
Cancer	1

Condition MeSH

Condition MeSH for Technetium Tc-99m Albumin Kit
Intervention	Trials
Carcinoma, Hepatocellular	2
Carcinoma	2
Lung Neoplasms	2
Melanoma	1

Clinical Trial Locations for Technetium Tc-99m Albumin Kit

Trials by Country

Trials by Country for Technetium Tc-99m Albumin Kit
Location	Trials
United States	7
United Kingdom	1

Trials by US State

Trials by US State for Technetium Tc-99m Albumin Kit
Location	Trials
Washington	4
North Carolina	1
Indiana	1
Utah	1

Clinical Trial Progress for Technetium Tc-99m Albumin Kit

Clinical Trial Phase

Clinical Trial Phase for Technetium Tc-99m Albumin Kit
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Technetium Tc-99m Albumin Kit
Clinical Trial Phase	Trials
Completed	2
Recruiting	2
Active, not recruiting	1

Clinical Trial Sponsors for Technetium Tc-99m Albumin Kit

Sponsor Name

Sponsor Name for Technetium Tc-99m Albumin Kit
Sponsor	Trials
National Cancer Institute (NCI)	2
University of Washington	2
Hoosier Cancer Research Network	2

Sponsor Type

Sponsor Type for Technetium Tc-99m Albumin Kit
Sponsor	Trials
Other	7
Industry	3
NIH	2

Technetium Tc-99m Albumin Kit: Clinical Trials, Market Analysis, and Projections

Introduction

Technetium Tc-99m Albumin Aggregated (MAA) Kit is a diagnostic radiopharmaceutical used primarily for lung imaging and the evaluation of peritoneovenous shunt patency. Here, we will delve into the clinical trials, market analysis, and future projections for this crucial diagnostic tool.

Clinical Trials and Safety Profile

The safety profile of Technetium Tc-99m MAA is well established, with over 30 years of clinical experience. The FDA has approved several formulations, including Pulmotech MAA, which is indicated for lung imaging in adults and pediatric patients, as well as for evaluating peritoneovenous shunt patency in adults[2][4].

Clinical trials and non-clinical reviews have highlighted the efficacy and safety of Technetium Tc-99m MAA. However, there are specific contraindications and warnings, such as severe pulmonary hypertension and a history of hypersensitivity reactions to albumin human. Deaths have been reported in patients with severe pulmonary hypertension, and thus, the administration of the lowest possible number of particles is recommended in such cases[4].

Mechanism of Action and Pharmacodynamics

Technetium Tc-99m MAA works by forming aggregated particles that, upon intravenous injection, are trapped in the arterioles and capillaries of the lung within 1 to 5 minutes. This allows for the imaging of pulmonary perfusion. When administered intraperitoneally, the technetium Tc-99m albumin aggregated mixes with the peritoneal fluid, aiding in the evaluation of shunt patency[4].

Market Analysis

Current Market Status

The Technetium-99m market, which includes Technetium Tc-99m MAA, is significant and growing. In 2023, the cardiovascular segment held the largest market share, primarily due to its role in myocardial perfusion imaging. North America, particularly the United States and Canada, dominates the global market due to advanced healthcare infrastructure and high prevalence of chronic diseases[3].

Market Size and Growth

The total Technetium-99m market is expected to grow at a CAGR of 4.05% from 2024 to 2030, reaching nearly USD 6.54 billion by 2030. This growth is driven by the increasing demand for Tc-99m-based radiopharmaceuticals in various clinical applications, including cardiovascular imaging, cancer detection, and respiratory imaging[3].

Regional Market

The United States is a major contributor to the Technetium-99m market, conducting over 40,000 Tc-99m-based imaging procedures daily. The region's advanced healthcare infrastructure and significant investments in medical imaging technology are key factors driving this market[3].

Market Projections

Increasing Demand for Diagnostic Procedures

The growing number of diagnostic procedures using Technetium-99m is expected to drive market growth. Technetium-99m is used in more than 80% of all nuclear medicine procedures in the United States, and this trend is likely to continue as new radiopharmaceuticals with improved specificity and sensitivity are developed[3].

Innovations in Radiopharmaceuticals

Ongoing research and development efforts are focused on creating new Tc-99m-based radiopharmaceuticals. These advancements are expected to increase the demand for Technetium-99m, as these new formulations are introduced into clinical practice. The development of more accurate and targeted imaging techniques will further boost the market[3].

Economic Factors

The global albumin market, which includes the albumin used in Technetium Tc-99m MAA, is also growing. The albumin market was valued at $4,813.5 million in 2020 and is estimated to reach $8,956.07 million by 2030, growing at a CAGR of 6.4% from 2021 to 2030. This growth in the albumin market will support the demand for Technetium Tc-99m MAA kits[5].

Key Challenges and Opportunities

Supply Chain and Production

One of the key challenges facing the Technetium-99m market is the reliable supply of the isotope. Technetium-99m is produced from molybdenum-99, and any disruptions in the supply chain can impact the availability of Technetium-99m. However, advancements in production technologies and the development of new production facilities are expected to mitigate these risks[3].

Regulatory Environment

The regulatory environment plays a crucial role in the approval and use of Technetium Tc-99m MAA kits. FDA approvals, such as the one for Pulmotech MAA, are critical for market entry. Compliance with regulatory requirements and ongoing safety monitoring are essential for maintaining market presence[2][4].

Conclusion

Technetium Tc-99m Albumin Aggregated Kit is a vital diagnostic tool in nuclear medicine, particularly for lung imaging and peritoneovenous shunt patency evaluation. With a well-established safety profile and ongoing clinical use, the market for this radiopharmaceutical is poised for growth driven by increasing demand for diagnostic procedures and innovations in radiopharmaceuticals.

Key Takeaways

• Established Safety Profile: Over 30 years of clinical experience with a well-documented safety profile.
• Growing Market: Expected to grow at a CAGR of 4.05% from 2024 to 2030, reaching nearly USD 6.54 billion.
• Increasing Demand: Driven by the growing number of diagnostic procedures and advancements in radiopharmaceuticals.
• Regional Dominance: North America, particularly the United States, dominates the global market.
• Challenges and Opportunities: Supply chain reliability and regulatory compliance are key factors.

FAQs

Q: What is the primary use of Technetium Tc-99m Albumin Aggregated Kit?

A: The primary use is for lung imaging and the evaluation of peritoneovenous shunt patency in adults and pediatric patients.

Q: What are the contraindications for Technetium Tc-99m MAA?

A: Contraindications include severe pulmonary hypertension and a history of hypersensitivity reactions to albumin human.

Q: How does Technetium Tc-99m MAA work?

A: Upon intravenous injection, the aggregated particles are trapped in the arterioles and capillaries of the lung, allowing for imaging of pulmonary perfusion.

Q: What is the expected market growth for Technetium-99m-based radiopharmaceuticals?

A: The market is expected to grow at a CAGR of 4.05% from 2024 to 2030, reaching nearly USD 6.54 billion by 2030.

Q: Which region dominates the global Technetium-99m market?

A: North America, particularly the United States and Canada, dominates the global market due to advanced healthcare infrastructure and high prevalence of chronic diseases.

Sources

1. Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Injection - University of New Mexico.
2. FDA NDA Review and Evaluation: Pulmotech MAA - FDA.
3. Technetium-99m Market: Industry Analysis and Forecast 2030 - Maximize Market Research.
4. Pulmotech MAA Label - FDA.
5. Global Albumin Market Report to 2030 - GlobeNewswire.

Last updated: 2025-01-07