CLINICAL TRIALS PROFILE FOR TECHNETIUM TC 99M TSC

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

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 Tsc

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.

Clinical Trial Conditions for Technetium Tc 99m Tsc

Condition Name

Condition Name for Technetium Tc 99m Tsc
Intervention	Trials
Breast Cancer	14
Healthy	4
Melanoma	4

Condition MeSH

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

Clinical Trial Locations for Technetium Tc 99m Tsc

Trials by Country

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

Clinical Trial Progress for Technetium Tc 99m Tsc

Clinical Trial Phase

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

Clinical Trial Sponsors for Technetium Tc 99m Tsc

Sponsor Name

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

Sponsor Type

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

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

Introduction to Technetium Tc 99m TSC

Technetium Tc 99m TSC (Technetium Tc 99m sulfur colloid) is a radiopharmaceutical widely used in nuclear medicine for various diagnostic procedures. It is particularly notable for its application in sentinel lymph node biopsies, liver, spleen, and bone marrow imaging, and in the evaluation of peritoneo-venous shunts[5].

Clinical Trials and Comparative Studies

Recent clinical trials have focused on comparing the efficacy of Technetium Tc 99m TSC with other radiopharmaceuticals, such as Tilmanocept. A prospective double-blinded randomized controlled trial compared the intraoperative injection of Technetium Tc 99m Tilmanocept with Technetium Tc 99m sulfur colloid (TSC) for sentinel lymph node biopsy. The study found no significant difference in the number of sentinel lymph nodes (SLNs) harvested or in the time to transcutaneous localization between the two agents. This indicates that both agents can be used interchangeably without any significant difference in performance[1].

Market Analysis

The Technetium Tc 99m market is experiencing robust growth driven by its essential role in medical diagnostics, particularly for chronic and non-communicable diseases.

Current Market Size and Growth Projections

As of 2023, the Technetium Tc 99m market was valued at approximately $6.0 billion and is projected to grow at a compound annual growth rate (CAGR) of 3.3% from 2024 to 2034, reaching over $8.6 billion by 2034[2].

Another analysis suggests that the market will grow at a CAGR of 4.05% from 2024 to 2030, reaching nearly $6.54 billion by 2030[4].

Market Segmentation

The Technetium Tc 99m market is segmented based on various applications, including:

• Cardiovascular Imaging: This segment holds the largest market share, primarily due to its critical role in myocardial perfusion imaging, which assesses blood flow to the heart muscle[4].
• Bone Scans: Used for diagnosing bone disorders and metastatic bone disease.
• Respiratory Imaging: For evaluating lung function and detecting respiratory diseases.
• Tumor Imaging: For diagnosing and monitoring various types of cancers.
• Other Applications: Including liver, spleen, and bone marrow imaging[4].

Geographic Distribution

The market is geographically diverse, with North America, particularly the United States and Canada, holding a significant share due to advanced healthcare infrastructure and high prevalence of chronic diseases. Europe, especially countries like Germany, France, and the U.K., also contribute substantially to the market. The Asia-Pacific region, including Japan, China, and India, is witnessing rapid growth due to investments in healthcare infrastructure and a growing focus on advanced diagnostics[2][4].

Technological Advancements and Research

New Radiopharmaceuticals Development

Ongoing research and development are focused on creating new Technetium Tc 99m-based radiopharmaceuticals with improved specificity and sensitivity. The International Atomic Energy Agency (IAEA) has initiated a Coordinated Research Project (CRP) to develop a new generation of Technetium Tc 99m kits and radiopharmaceuticals. This project aims to produce radiopharmaceuticals for imaging various biological substrates, including cancerous lesions, and to enhance quality control and preclinical studies[3].

Quality Control and Preclinical Studies

The CRP will focus on developing standard procedures and guidelines for the production, quality control, and preclinical studies of novel Technetium Tc 99m radiopharmaceuticals. This includes identifying efficient quality control procedures and preclinical assays to ensure the overall quality of the radiopharmaceuticals prepared during the project[3].

Market Drivers

Rising Healthcare Demands

The increasing demand for high-quality diagnostic imaging, particularly in non-invasive methods such as SPECT (Single Photon Emission Computed Tomography) and Gamma Cameras, is driving the growth of the Technetium Tc 99m market[2].

Advancements in Medical Imaging Technologies

Advancements in medical imaging technologies and the development of new radiopharmaceutical products are crucial for the market's growth. Technetium Tc 99m's ideal properties, such as a short half-life of 6 hours and optimal gamma energy for imaging, make it a preferred choice in nuclear medicine[4].

Collaborations and Mergers

The market is characterized by an increasing focus on collaborations and mergers to enhance product portfolios, improve supply chains, and invest in next-generation radiopharmaceuticals. These collaborations are expected to drive market growth by ensuring the availability of high-quality Technetium Tc 99m and expanding its applications in new diagnostic areas[2].

Key Takeaways

• Clinical Equivalence: Technetium Tc 99m TSC and Tilmanocept have been shown to be clinically equivalent in sentinel lymph node biopsies.
• Market Growth: The Technetium Tc 99m market is projected to grow significantly, driven by rising healthcare demands and advancements in medical imaging technologies.
• Segmentation: The market is segmented into various applications, with cardiovascular imaging holding the largest share.
• Geographic Distribution: North America and Europe are significant markets, with the Asia-Pacific region showing rapid growth.
• Technological Advancements: Ongoing research is focused on developing new radiopharmaceuticals with improved specificity and sensitivity.

FAQs

Q: What is Technetium Tc 99m TSC used for?

Technetium Tc 99m TSC is used for various diagnostic procedures, including sentinel lymph node biopsies, liver, spleen, and bone marrow imaging, and evaluating peritoneo-venous shunts[5].

Q: How does Technetium Tc 99m compare to Tilmanocept in clinical trials?

Clinical trials have shown no significant difference in the number of sentinel lymph nodes harvested or in the time to transcutaneous localization between Technetium Tc 99m TSC and Tilmanocept[1].

Q: What is the projected market size of Technetium Tc 99m by 2034?

The Technetium Tc 99m market is projected to reach over $8.6 billion by 2034[2].

Q: Which segment holds the largest market share in the Technetium Tc 99m market?

The cardiovascular imaging segment holds the largest market share due to its critical role in myocardial perfusion imaging[4].

Q: What are the key drivers of the Technetium Tc 99m market growth?

The key drivers include rising healthcare demands, advancements in medical imaging technologies, and collaborations to enhance product portfolios and supply chains[2][4].

Sources

1. Ferez-Pinzon, A., et al. "A Prospective Double‐Blinded Randomized Controlled Trial Comparing the Intraoperative Injection of Technetium Tc 99m Tilmanocept with Technetium Tc 99m Sulfur Colloid." Wiley Online Library, 30 July 2022.
2. Transparency Market Research. "Technetium-99m Market Poised for Growth, Projected to Reach Over US$ 8.6 Billion by 2034." GlobeNewswire, 28 November 2024.
3. IAEA. "New CRP to Develop new Technetium-99m Radiopharmaceuticals for Disease Diagnosis." IAEA News Center, 24 November 2023.
4. Maximize Market Research. "Technetium-99m Market: Industry Analysis and Forecast 2030." Maximize Market Research, 2024.
5. Drugs.com. "Technetium TC 99m TSC (Injection) - Sulfur colloid." Drugs.com, 29 April 2024.