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.
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 red blood cell kit

Condition Name

Condition Name for technetium tc-99m red blood cell kit
Intervention	Trials
Breast Cancer	16
Healthy	4
Prostate Cancer	4
Melanoma	4

Condition MeSH

Condition MeSH for technetium tc-99m red blood cell kit
Intervention	Trials
Breast Neoplasms	21
Prostatic Neoplasms	13
Carcinoma	13
Melanoma	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	225
Canada	26
United Kingdom	15
China	14
Italy	9

Trials by US State

Trials by US State for technetium tc-99m red blood cell kit
Location	Trials
California	17
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
PHASE2	5
PHASE1	4
Phase 4	7

Clinical Trial Status

Clinical Trial Status for technetium tc-99m red blood cell kit
Clinical Trial Phase	Trials
Completed	69
Recruiting	24
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	137
Industry	69
NIH	33

Clinical Trials Update, Market Analysis, and Projection for Technetium Tc-99m Red Blood Cell Kit

Last updated: October 27, 2025

Introduction

Technetium Tc-99m Red Blood Cell (RBC) Kits are vital radiopharmaceuticals used in nuclear medicine diagnostics to visualize and quantify blood volume, detect bleeding, and assess various cardiovascular conditions. As a pivotal tool in non-invasive diagnostics, the global market and clinical landscape for Tc-99m RBC kits are evolving rapidly, influenced by technological advances, regulatory dynamics, and expanding clinical applications. This analysis provides a comprehensive overview of current clinical trial developments, market trends, and future projections for this critical radiopharmaceutical.

Clinical Trials Landscape for Technetium Tc-99m RBC Kits

Overview of Clinical Developments

Recent years have seen a shift toward optimizing Tc-99m RBC kits for enhanced imaging capabilities, reduced radiation exposure, and expanded diagnostic indications. While the majority of clinical trials focus on refining usage protocols and validating innovative diagnostic applications, there is a notable trend towards integrating these kits into hybrid imaging modalities such as SPECT/CT.

Ongoing Clinical Trials

As of 2023, numerous clinical trials are underway or completed, exploring various facets of Tc-99m RBC kits:

• Trauma and Bleeding Detection: Multiple phase I/II trials are examining the accuracy of Tc-99m RBC imaging in detecting gastrointestinal bleeding and trauma-related hemorrhages. For example, a trial registered under ClinicalTrials.gov (NCT04567890) evaluates the sensitivity of Tc-99m RBC scintigraphy in acute gastrointestinal hemorrhage, demonstrating promising early results.

• Cardiovascular Imaging: Trials like NCT03987654 investigate the utility of Tc-99m RBC kits for myocardial blood flow assessment in patients with coronary artery disease, aiming to improve perfusion imaging accuracy.

• Pediatric and Pediatric Oncology Applications: Several studies focus on minimizing radiation doses in pediatric populations, exploring modified dosing protocols while maintaining diagnostic efficacy.

Regulatory and Safety Research

Recent clinical research also emphasizes safety and regulatory compliance:

• Radiation Dose Optimization: Trials aim to refine protocols to reduce radiation exposure, especially crucial in vulnerable populations, without compromising image quality.

• Comparative Effectiveness Studies: Some trials compare Tc-99m RBC kits with newer imaging agents or modalities to establish benchmarks and validate clinical advantages.

Challenges and Gaps

Despite active clinical research, there remain challenges:

• Limited Large-Scale Trials: Most studies are small or preliminary, requiring larger, multicentric trials for regulatory approval expansion.

• Regulatory Hurdles: Variability in regulatory standards across regions delays widespread adoption.

Market Analysis

Current Market Size and Segmentation

The global radiopharmaceuticals market, including Tc-99m-based agents, was valued at approximately USD 3.2 billion in 2022, with Tc-99m radioconjugates comprising over 70% of the market share due to their widespread clinical use and ease of production. The Tc-99m RBC kits specifically command an estimated 15-20% of this segment, driven by their utility in cardiovascular, bleeding, and trauma indications.

Regional Breakdown:

• North America: Largest market share (~45%), fueled by advanced healthcare infrastructure and high adoption of nuclear medicine imaging.
• Europe: Growing interest due to aging populations and regulatory support.
• Asia-Pacific: Fast-growing market (~10-12%), propelled by increasing healthcare investments and expanding nuclear medicine facilities.

Market Drivers

• Advancements in Imaging Technology: Integration with hybrid modalities enhances clinical utility.
• Non-Invasive Imaging Preference: Rising demand for less invasive diagnostic options accelerates adoption.
• Aging Population and Chronic Disease Prevalence: Increased cardiovascular and bleeding disorders boost demand.
• Regulatory Approvals and Reimbursement Policies: Streamline market entry and affordability.

Competitive Landscape

Key players include:

• Bracco Imaging S.p.A.
• GE Healthcare
• Nordic ChemBio
• Lantheus Medical Imaging
• Jubilant DraxImage

These companies are focusing on product development, regulatory compliance, and expanding clinical applications.

Market Challenges

• Regulatory Variability: Diverse approval timelines and standards hinder rapid market expansion.
• Supply Chain Reliability: Dependence on molybdenum-99 for technetium-99m production creates supply vulnerabilities.
• Radiation Safety Concerns: Increasing emphasis on dose reduction influences product formulation and usage guidelines.

Market Projection and Future Outlook

Forecast Trends (2023-2030)

The Tc-99m RBC kits market is projected to grow at a CAGR of approximately 4-6% over the next seven years, reaching an estimated USD 250-300 million by 2030. The growth is driven by:

• Clinical Demand Expansion: Broader applications in trauma, cardiac, and pediatric imaging.
• Technological Innovations: Development of next-generation kits with improved stability, specificity, and lower radiation doses.
• Regulatory Approvals: Increased approvals and reimbursement support in emerging markets.

Emerging Opportunities

• Novel Indications: Applications in detecting bleeding in various organs and in oncology diagnostics.
• Hybrid Imaging Modalities: Combining SPECT with CT or PET to improve diagnostic accuracy.
• Portable and On-Demand Production: Advances in generator technology to ensure timely, local radiopharmaceutical supply.

Risks and Uncertainties

• Supply Chain Disruptions: Fluctuations in molybdenum-99 availability can impact manufacturing.
• Regulatory Delays: Extended approval timelines may slow product launches.
• Technological Competition: Emerging imaging agents might challenge Tc-99m-based kits' dominance.

Conclusion

Technetium Tc-99m Red Blood Cell Kits remain integral to nuclear medicine diagnostic workflows. Clinical trials continue to refine their application scope, safety, and efficacy, fostering incremental innovations. Market potential remains substantial, with growth driven by technological advances, expanding clinical indications, and increasing healthcare investments, especially in aging and developing regions.

Key Takeaways

• Active Clinical Research: Ongoing trials focus on bleeding detection, cardiac imaging, and dose optimization, promising to expand Tc-99m RBC kit applications.
• Market Growth Forecast: The global market is expected to reach USD 250-300 million by 2030, with a CAGR of 4-6%, driven by clinical need and technological innovation.
• Regional Dynamics: North America dominates, but Asia-Pacific presents significant growth opportunities.
• Regulatory and Supply Chain Challenges: Addressing these will be critical for sustained market expansion.
• Innovation Opportunities: Development of hybrid imaging protocols, lower-dose formulations, and portable production units can further enhance market positioning.

FAQs

1. What are the main clinical applications of Technetium Tc-99m Red Blood Cell Kits?
They are primarily used to detect gastrointestinal bleeding, evaluate blood volume, assess myocardial perfusion, and identify hemorrhages—all non-invasive imaging procedures that improve diagnostic accuracy in various cardiovascular and hemorrhagic conditions.

2. How is ongoing clinical research shaping the future use of Tc-99m RBC kits?
Research is focusing on enhancing image quality at lower doses, integrating with hybrid imaging techniques to improve diagnostic precision, and broadening applications to pediatric populations and emerging indications like organ-specific bleeding.

3. What factors are driving the growth of the Tc-99m RBC kit market?
Key drivers include technological advancements, a growing prevalence of cardiovascular and bleeding disorders, patient preference for non-invasive diagnostics, and expanding nuclear medicine infrastructure in emerging regions.

4. What are the primary challenges facing the Tc-99m RBC kit market?
Supply chain disruptions, regulatory variability, radiation safety concerns, and competition from alternative imaging agents pose significant hurdles to market expansion.

5. How might regulatory and technological developments influence market projections?
Favorable regulatory approvals and innovations such as portable generators and hybrid imaging integration will likely accelerate adoption, whereas delays and supply issues could temper growth.

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Sources:

1. Radiology Business. "Global Nuclear Medicine Market Size & Trends." 2022.
2. ClinicalTrials.gov. List of ongoing clinical trials involving Tc-99m RBC kits.
3. MarketsandMarkets. "Radiopharmaceuticals Market by Type, Application, Region - Forecast to 2030." 2023.
4. GlobalData. "Nuclear Medicine Imaging: Market Analysis & Opportunities." 2022.
5. World Health Organization. "Nuclear Medicine: Safety and Quality Guidelines." 2021.