CLINICAL TRIALS PROFILE FOR TECHNETIUM TC-99M RED BLOOD CELL KIT

505(b)(2) Clinical Trials for Technetium Tc-99m Red Blood Cell Kit

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	Simbec Research	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	AstraZeneca	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.

All Clinical Trials for Technetium Tc-99m Red Blood Cell Kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001003 ↗	A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with advanced HIV disease and T4 cell count < 200 cells/mm3. To establish the range of pentamidine (PEN) deposition in AIDS patients participating in ACTG 021 and ACTG 081. To identify factors (breathing pattern, pulmonary function) that may be important in affecting the actual dose delivered to a given patient. The specific system that is used to deliver PEN to the lungs may determine whether a therapeutically effective dose is attained in the lungs. Therefore, this study will establish the amount of PEN that is deposited in the lungs of patients enrolled in protocols ACTG 021 and ACTG 081, who are being treated with PEN administered from the Marquest Respirgard II nebulizer.
NCT00001277 ↗	Studies of Elevated Parathyroid Activity	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)		1993-12-15	Patients whose parathyroid activity is elevated above normal are referred to as having hyperparathyroidism. This study will help researchers better understand the causes of hyperthyroidism and to evaluate and improve methods for diagnosis and treatment. In this study, patients diagnosed with or suspected of having hyperparathyroidism will be selected to participate. In addition, patients with related conditions such as parathyroid tumors, will also be selected. Subjects will be asked to provide blood and urine for testing to confirm their condition. They will then be surgically treated by removal of the parathyroid gland(s) (parathyroidectomy). Subjects with parathyroid tumors will undergo several diagnostic tests to determine the exact location of the tumor as well as the tumor's activity. The tests may include; ultrasounds, nuclear scanning, CT scans, MRI, and specialized blood testing. Sometimes parathyroidectomy leads to hypoparathyroidism. Options for treating the patients after the surgical procedure will also be addressed. Calcium and Vitamin D supplements are typically the mainstay of post parathyroidectomy therapy. Other potential treatments include transplanting the parathyroid gland(s) to other areas of the body.
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.
NCT00004705 ↗	Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis	Completed	University of North Carolina	N/A	1996-09-01	OBJECTIVES: I. Determine the stability of uridine triphosphate (UTP) and examine the metabolism of exogenous nucleotides on airway epithelial surfaces in patients with cystic fibrosis. II. Determine the acute safety and efficacy of aerosolized UTP in children with cystic fibrosis.
NCT00004705 ↗	Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis	Completed	FDA Office of Orphan Products Development	N/A	1996-09-01	OBJECTIVES: I. Determine the stability of uridine triphosphate (UTP) and examine the metabolism of exogenous nucleotides on airway epithelial surfaces in patients with cystic fibrosis. II. Determine the acute safety and efficacy of aerosolized UTP in children with cystic fibrosis.
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.

Clinical Trial Conditions for Technetium Tc-99m Red Blood Cell Kit

Condition Name

Condition Name for Technetium Tc-99m Red Blood Cell Kit
Intervention	Trials
Breast Cancer	14
Healthy	4
Melanoma	4
Prostate Cancer	3

Condition MeSH

Condition MeSH for Technetium Tc-99m Red Blood Cell Kit
Intervention	Trials
Breast Neoplasms	18
Carcinoma	13
Prostatic Neoplasms	11
Neoplasms	7

Clinical Trial Locations for Technetium Tc-99m Red Blood Cell Kit

Trials by Country

Trials by Country for Technetium Tc-99m Red Blood Cell Kit
Location	Trials
United States	223
Canada	26
United Kingdom	15
China	11
Italy	9

Trials by US State

Trials by US State for Technetium Tc-99m Red Blood Cell Kit
Location	Trials
California	16
Texas	15
Washington	13
Pennsylvania	12
New York	12

Clinical Trial Progress for Technetium Tc-99m Red Blood Cell Kit

Clinical Trial Phase

Clinical Trial Phase for Technetium Tc-99m Red Blood Cell Kit
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	15
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Technetium Tc-99m Red Blood Cell Kit
Clinical Trial Phase	Trials
Completed	67
Recruiting	20
Terminated	15

Clinical Trial Sponsors for Technetium Tc-99m Red Blood Cell Kit

Sponsor Name

Sponsor Name for Technetium Tc-99m Red Blood Cell Kit
Sponsor	Trials
National Cancer Institute (NCI)	20
Endocyte	9
Mayo Clinic	8

Sponsor Type

Sponsor Type for Technetium Tc-99m Red Blood Cell Kit
Sponsor	Trials
Other	117
Industry	67
NIH	33

Technetium Tc-99m Red Blood Cell Kit: Clinical Trials, Market Analysis, and Projections

Introduction

Technetium Tc-99m red blood cells are a diagnostic radiopharmaceutical agent used extensively in medical imaging, particularly for blood pool imaging, including cardiac first pass and gated equilibrium imaging, and for the detection of gastrointestinal bleeding. Here, we will delve into the clinical trials, market analysis, and future projections for this diagnostic kit.

Clinical Trials and Efficacy

Mechanism of Action and Labeling Efficiency

The technetium Tc-99m red blood cell kit involves the radiolabeling of autologous red blood cells with sodium pertechnetate Tc-99m. This process is highly efficient, with labeling efficiencies typically exceeding 95%[1][2].

Clinical Studies

Several studies have evaluated the efficacy and safety of technetium Tc-99m red blood cells. For instance, a study comparing the radiolabeling technique using technetium Tc-99m to the standard chromium-51 method showed no significant difference in labeling efficiency and highlighted a significant reduction in radiation dose, making it a superior technique for pediatric patients[5].

Specific Applications

• Cardiac Imaging: Technetium Tc-99m red blood cells are used for cardiac first pass and gated equilibrium imaging, providing valuable insights into cardiac function and structure[2].
• Gastrointestinal Bleeding: The kit is effective in detecting and localizing sites of gastrointestinal bleeding, aiding in the early diagnosis and management of such conditions[2].

Market Analysis

Current Market Status

The market for diagnostic radiopharmaceuticals, including technetium Tc-99m red blood cells, is driven by the increasing demand for advanced diagnostic tools in nuclear medicine. The global nuclear medicine market is expected to grow significantly, with a substantial portion attributed to diagnostic agents like technetium Tc-99m[2].

Key Players and Competition

Major pharmaceutical and diagnostic companies are involved in the production and distribution of technetium Tc-99m red blood cell kits. The competition in this market is moderate, with several players offering similar products, but the specificity and efficiency of the UltraTag RBC kit make it a preferred choice in many clinical settings[1].

Market Drivers

• Advancements in Nuclear Medicine: Continuous advancements in nuclear medicine and the development of new imaging techniques are driving the demand for technetium Tc-99m red blood cells.
• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of cardiovascular diseases and gastrointestinal disorders necessitates the use of advanced diagnostic tools, contributing to market growth.
• Regulatory Approvals: Regulatory approvals and guidelines supporting the use of technetium Tc-99m red blood cells further bolster market confidence and adoption[2].

Market Projections

Growth Forecast

The global market for technetium Tc-99m red blood cells is projected to grow at a steady rate over the next decade. This growth is anticipated due to the increasing adoption of nuclear medicine in clinical practice, advancements in imaging technologies, and the expanding need for precise diagnostic tools.

Emerging Markets

Emerging markets, particularly in Asia and Latin America, are expected to contribute significantly to the growth of the technetium Tc-99m red blood cell market. These regions are witnessing rapid advancements in healthcare infrastructure and an increasing demand for advanced diagnostic services.

Technological Advancements

Future technological advancements, such as improvements in radiolabeling techniques and the development of new imaging modalities, are likely to enhance the market potential of technetium Tc-99m red blood cells. For example, the use of more efficient radiolabeling methods could reduce the time and complexity associated with the current process, making it more appealing to a broader range of healthcare providers[5].

Regulatory Environment

FDA and International Regulations

The technetium Tc-99m red blood cell kit is subject to stringent regulatory guidelines. In the United States, the FDA oversees the approval and use of such diagnostic agents. Compliance with these regulations is crucial for market entry and continued use. International regulations also play a significant role, with varying standards across different countries that manufacturers must adhere to[1].

Safety and Adverse Effects

Common Adverse Effects

While technetium Tc-99m red blood cells are generally safe, there are potential adverse effects to consider. These include allergic reactions, although rare, and the risk of hemolysis if the blood is not properly anticoagulated[1][2].

Radiation Safety

Given that technetium Tc-99m is a radioactive substance, radiation safety is a critical concern. Proper handling, storage, and disposal of the kit components are essential to minimize exposure to healthcare workers and patients. The physical half-life of technetium Tc-99m is approximately 6.02 hours, which helps in managing radiation exposure[2].

Conclusion

Technetium Tc-99m red blood cells represent a vital diagnostic tool in nuclear medicine, offering high labeling efficiency and specific applications in cardiac and gastrointestinal imaging. The market for this diagnostic kit is expected to grow, driven by advancements in nuclear medicine, increasing prevalence of relevant diseases, and regulatory approvals.

Key Takeaways

• High Labeling Efficiency: Technetium Tc-99m red blood cells achieve labeling efficiencies of over 95%.
• Specific Applications: Used for cardiac first pass, gated equilibrium imaging, and detection of gastrointestinal bleeding.
• Market Growth: Driven by advancements in nuclear medicine and increasing demand for advanced diagnostic tools.
• Regulatory Compliance: Subject to FDA and international regulatory guidelines.
• Safety Considerations: Potential for allergic reactions and hemolysis; strict radiation safety protocols are necessary.

FAQs

What is the primary use of technetium Tc-99m red blood cells?

Technetium Tc-99m red blood cells are primarily used for blood pool imaging, including cardiac first pass and gated equilibrium imaging, and for the detection of gastrointestinal bleeding.

How efficient is the labeling process of technetium Tc-99m red blood cells?

The labeling process typically achieves an efficiency of over 95%.

What are the key components of the UltraTag RBC kit?

The kit includes a reaction vial with stannous chloride, sodium citrate, and dextrose, along with syringes for the addition of sodium pertechnetate Tc-99m.

What are the potential adverse effects of technetium Tc-99m red blood cells?

Potential adverse effects include allergic reactions and the risk of hemolysis if the blood is not properly anticoagulated.

How long does technetium Tc-99m remain in the blood pool?

Technetium Tc-99m is well retained in the blood pool with an estimated biological half-life of approximately 29 hours.

Sources

1. UltraTag RBC: Package Insert / Prescribing Information - Drugs.com
2. Technetium Tc-99m red blood cells - DrugBank
3. FDA Approves Enjaymo® after pivotal study results - Sanofi
4. A Case Study Report - Journal of Nuclear Medicine Technology
5. Evaluation and testing of in vitro labeled technetium Tc-99m red ... - PubMed