CLINICAL TRIALS PROFILE FOR TECHNETIUM TC 99M HSA

505(b)(2) Clinical Trials for Technetium Tc 99m Hsa

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 Hsa

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.
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.

Clinical Trial Conditions for Technetium Tc 99m Hsa

Condition Name

Condition Name for Technetium Tc 99m Hsa
Intervention	Trials
Breast Cancer	14
Healthy	4
Melanoma	4
Prostate Cancer	3

Condition MeSH

Condition MeSH for Technetium Tc 99m Hsa
Intervention	Trials
Breast Neoplasms	18
Carcinoma	13
Prostatic Neoplasms	11
Neoplasms	7

Clinical Trial Locations for Technetium Tc 99m Hsa

Trials by Country

Trials by Country for Technetium Tc 99m Hsa
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 Hsa
Location	Trials
California	16
Texas	15
Washington	13
Pennsylvania	12
New York	12

Clinical Trial Progress for Technetium Tc 99m Hsa

Clinical Trial Phase

Clinical Trial Phase for Technetium Tc 99m Hsa
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 Hsa
Clinical Trial Phase	Trials
Completed	67
Recruiting	20
Terminated	15

Clinical Trial Sponsors for Technetium Tc 99m Hsa

Sponsor Name

Sponsor Name for Technetium Tc 99m Hsa
Sponsor	Trials
National Cancer Institute (NCI)	20
Endocyte	9
Mayo Clinic	8

Sponsor Type

Sponsor Type for Technetium Tc 99m Hsa
Sponsor	Trials
Other	117
Industry	67
NIH	33

Technetium Tc 99m HSA: Clinical Trials, Market Analysis, and Projections

Introduction

Technetium-99m (Tc-99m) labeled human serum albumin (HSA) is a radiopharmaceutical widely used in nuclear medicine for various diagnostic purposes. This article delves into the clinical trials, market analysis, and future projections of Tc-99m HSA, highlighting its significance and growth potential.

Clinical Applications and Trials

Diagnosis of Protein-Losing Enteropathy (PLE)

Tc-99m HSA has been effectively used in diagnosing protein-losing enteropathy (PLE). A study involving 26 patients suspected of having PLE showed that Tc-99m HSA scintigraphy was highly reliable, with 25 out of 26 scans indicating activity in the bowel, confirming the presence of PLE. This method is particularly useful as it can identify sites of protein loss and is convenient to perform, yielding results within 24 hours[1].

Pre-Radioembolization Imaging

In the context of radioembolization, Tc-99m HSA microspheres are used to assess liver-lung shunt (LLS) and biodistribution. A clinical trial comparing Tc-99m HSA microspheres with macroaggregated albumin (MAA) microspheres found that Tc-99m HSA microspheres are more resistant to degradation, providing reliable LLS determination even at later time points. This stability is crucial for accurate pre-treatment assessments[4].

Market Analysis

Current Market Size and Growth

The Tc-99m market, which includes Tc-99m HSA, was valued at approximately USD 4.95 billion in 2023. It is projected to grow at a Compound Annual Growth Rate (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, bone scans, and tumor imaging[2].

Market Segmentation

The Tc-99m market is segmented by application, with the cardiovascular segment holding the largest market share. Tc-99m is extensively used in myocardial perfusion imaging to evaluate cardiovascular disease, cardiac stress, and myocardial infarction. Other significant segments include bone scans, respiratory imaging, and tumor imaging[2].

Geographical Distribution

North America, particularly the United States and Canada, dominates the global Tc-99m 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[2].

Market Drivers and Trends

Increasing Demand for Advanced Imaging

The demand for Tc-99m-based radiopharmaceuticals is fueled by the need for advanced nuclear imaging techniques. Single Photon Emission Computed Tomography (SPECT) imaging, which often uses Tc-99m, is a widely adopted method in emerging markets like China, where healthcare infrastructure is rapidly developing[2].

Technological Advancements

Advancements in Tc-99m radiopharmaceuticals, such as improved specificity and sensitivity, are driving market growth. New radiopharmaceutical products based on Tc-99m are being developed to enhance diagnostic accuracy and targeted imaging of various diseases, including cancer, cardiovascular disease, and neurological disorders[2].

Regulatory and Healthcare Initiatives

Governments are implementing health programs to increase diagnostic imaging and treatment options, which further bolsters the demand for Tc-99m. The expansion of health infrastructure and increased healthcare expenditure globally are key factors contributing to the market's growth[3].

Future Projections

Market Growth and Opportunities

The Tc-99m market is expected to continue growing, driven by the increasing need for early disease detection and precise imaging techniques. By 2034, the market is projected to reach USD 8.6 billion, growing at a CAGR of 3.3% from 2024 to 2034[3].

Emerging Markets

Emerging markets, particularly in Asia, present significant opportunities for the Tc-99m market. The rising demand for reliable and cost-effective diagnostic tools in these regions is expected to fuel market growth[2].

Innovation and Research

Ongoing research and development in Tc-99m-based radiopharmaceuticals are expected to introduce new products with improved clinical potential. However, overcoming regulatory hurdles and reducing the high costs associated with compliance will be crucial for the widespread adoption of these new products[5].

"Technetium-99m radiopharmaceuticals are applied in morphological and dynamic imaging of many organs in the body, to diagnose various diseases. It is estimated that about 25 million diagnostic investigations are performed annually using this single isotope."[5]

Key Takeaways

• Clinical Efficacy: Tc-99m HSA is highly effective in diagnosing conditions like PLE and in pre-radioembolization imaging.
• Market Growth: The Tc-99m market is projected to grow significantly, driven by increasing demand for advanced imaging techniques.
• Segmentation: The cardiovascular segment dominates the market, with other significant segments including bone scans, respiratory imaging, and tumor imaging.
• Geographical Dominance: North America, particularly the U.S. and Canada, leads the global market due to advanced healthcare infrastructure.
• Future Projections: The market is expected to reach USD 8.6 billion by 2034, with emerging markets and ongoing research driving growth.

FAQs

What is Technetium-99m (Tc-99m) used for?

Tc-99m is used in various nuclear medicine applications, including cardiovascular imaging, bone scans, respiratory imaging, and tumor imaging.

How is Tc-99m HSA used in clinical trials?

Tc-99m HSA is used in diagnosing protein-losing enteropathy (PLE) and in pre-radioembolization imaging to assess liver-lung shunt (LLS) and biodistribution.

What is the current market size of the Tc-99m market?

The Tc-99m market was valued at approximately USD 4.95 billion in 2023.

What drives the growth of the Tc-99m market?

The growth is driven by the increasing demand for advanced nuclear imaging techniques, technological advancements in radiopharmaceuticals, and government health initiatives.

Which region dominates the global Tc-99m market?

North America, particularly the United States and Canada, dominates the global Tc-99m market.

What are the future projections for the Tc-99m market?

The market is expected to reach USD 8.6 billion by 2034, growing at a CAGR of 3.3% from 2024 to 2034.

Sources

1. Protein-losing enteropathy: diagnosis with (99m)Tc-labeled human serum albumin scintigraphy. PubMed.
2. Technetium-99m Market: Industry Analysis and Forecast 2030. Maximize Market Research.
3. Technetium-99m Market Size, Share, Growth & Overview, 2034. Transparency Market Research.
4. 99m Tc-HSA-Microspheres Used in Preradioembolization. Journal of Nuclear Medicine.
5. Technetium-99m Radiopharmaceuticals: Status and Trends. International Atomic Energy Agency.