CLINICAL TRIALS PROFILE FOR TECHNETIUM TC-99M LABELED CARBON

All Clinical Trials for TECHNETIUM TC-99M LABELED CARBON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01248221 ↗	Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)	Completed	Advanced Breath Diagnostics, LLC	N/A	2010-12-01	The purpose of this study is to compare stomach emptying using 13C-Spirulina platensis breath test and scintigraphy in healthy subjects and subjects with dyspepsia. Subjects will eat a standard meal of 2 scrambled eggs, a slice of wheat toast and 8 ounces of skim milk. The eggs will be double labeled with Technetium-99m (99mTc) sulfur colloid and 13C-Spirulina platensis. Scintigraphy is a diagnostic technique in which a two-dimensional picture of internal body tissue is produced through the detection of radiation emitted by a radioactive substance administered into the body. The location of a standard meal in the digestive system will be measured by images of the 99mTc sulfur colloid taken at periodic intervals before and after the standard meal. The 99mTc Sulfur Colloid is approved by the FDA for use in medical diagnostic procedures. Spirulina platensis is blue - green algae, which is very similar to the naturally occurring spirulina sold in health food stores as a dietary supplement. The spirulina platensis has been labeled with the 13C stable isotope. 13C stable isotope labeling is inherently safe as 1.1% of all carbon in our bodies and in the food we eat is 13C. The presence of the 13C will be measured by breath samples at periodic intervals before and after a standard meal. The FDA considers 13C-Spirulina platensis to be investigational for the purposes of this study.
NCT01248221 ↗	Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)	Completed	National Center for Research Resources (NCRR)	N/A	2010-12-01	The purpose of this study is to compare stomach emptying using 13C-Spirulina platensis breath test and scintigraphy in healthy subjects and subjects with dyspepsia. Subjects will eat a standard meal of 2 scrambled eggs, a slice of wheat toast and 8 ounces of skim milk. The eggs will be double labeled with Technetium-99m (99mTc) sulfur colloid and 13C-Spirulina platensis. Scintigraphy is a diagnostic technique in which a two-dimensional picture of internal body tissue is produced through the detection of radiation emitted by a radioactive substance administered into the body. The location of a standard meal in the digestive system will be measured by images of the 99mTc sulfur colloid taken at periodic intervals before and after the standard meal. The 99mTc Sulfur Colloid is approved by the FDA for use in medical diagnostic procedures. Spirulina platensis is blue - green algae, which is very similar to the naturally occurring spirulina sold in health food stores as a dietary supplement. The spirulina platensis has been labeled with the 13C stable isotope. 13C stable isotope labeling is inherently safe as 1.1% of all carbon in our bodies and in the food we eat is 13C. The presence of the 13C will be measured by breath samples at periodic intervals before and after a standard meal. The FDA considers 13C-Spirulina platensis to be investigational for the purposes of this study.
NCT01248221 ↗	Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A	2010-12-01	The purpose of this study is to compare stomach emptying using 13C-Spirulina platensis breath test and scintigraphy in healthy subjects and subjects with dyspepsia. Subjects will eat a standard meal of 2 scrambled eggs, a slice of wheat toast and 8 ounces of skim milk. The eggs will be double labeled with Technetium-99m (99mTc) sulfur colloid and 13C-Spirulina platensis. Scintigraphy is a diagnostic technique in which a two-dimensional picture of internal body tissue is produced through the detection of radiation emitted by a radioactive substance administered into the body. The location of a standard meal in the digestive system will be measured by images of the 99mTc sulfur colloid taken at periodic intervals before and after the standard meal. The 99mTc Sulfur Colloid is approved by the FDA for use in medical diagnostic procedures. Spirulina platensis is blue - green algae, which is very similar to the naturally occurring spirulina sold in health food stores as a dietary supplement. The spirulina platensis has been labeled with the 13C stable isotope. 13C stable isotope labeling is inherently safe as 1.1% of all carbon in our bodies and in the food we eat is 13C. The presence of the 13C will be measured by breath samples at periodic intervals before and after a standard meal. The FDA considers 13C-Spirulina platensis to be investigational for the purposes of this study.

Clinical Trial Conditions for TECHNETIUM TC-99M LABELED CARBON

Condition Name

Condition Name for TECHNETIUM TC-99M LABELED CARBON
Intervention	Trials
Dyspepsia	1

Condition MeSH

Condition MeSH for TECHNETIUM TC-99M LABELED CARBON
Intervention	Trials
Dyspepsia	1

Clinical Trial Locations for TECHNETIUM TC-99M LABELED CARBON

Trials by Country

Trials by Country for TECHNETIUM TC-99M LABELED CARBON
Location	Trials
United States	1

Trials by US State

Trials by US State for TECHNETIUM TC-99M LABELED CARBON
Location	Trials
Minnesota	1

Clinical Trial Progress for TECHNETIUM TC-99M LABELED CARBON

Clinical Trial Phase

Clinical Trial Phase for TECHNETIUM TC-99M LABELED CARBON
Clinical Trial Phase	Trials
N/A	1

Clinical Trial Status

Clinical Trial Status for TECHNETIUM TC-99M LABELED CARBON
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for TECHNETIUM TC-99M LABELED CARBON

Sponsor Name

Sponsor Name for TECHNETIUM TC-99M LABELED CARBON
Sponsor	Trials
Mayo Clinic	1
Advanced Breath Diagnostics, LLC	1
National Center for Research Resources (NCRR)	1

Sponsor Type

Sponsor Type for TECHNETIUM TC-99M LABELED CARBON
Sponsor	Trials
NIH	2
Other	2

Clinical Trials Update, Market Analysis, and Projection for Technetium TC-99m Labeled Carbon

Last updated: October 30, 2025

Introduction

Technetium-99m (Tc-99m) labeled carbon compounds represent a promising development in nuclear medicine, leveraging Tc-99m’s optimal gamma emission and short half-life for precise imaging. The use of Tc-99m labeled carbon-based radiopharmaceuticals aims to enhance diagnostic accuracy in various imaging applications, particularly in cardiology and neurology. This report provides an in-depth overview of current clinical trials, analyzes the market landscape, and offers projections for the growth of Tc-99m labeled carbon products.

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Clinical Trials Update

Ongoing and Recent Clinical Studies

Recent clinical research emphasizes the safety, efficacy, and diagnostic advantages of Tc-99m labeled carbon compounds. Several trials are evaluating their application across multiple diagnostic domains:

• Cardiac Imaging: Multiple Phase I and II trials are exploring Tc-99m labeled carbon tracers for myocardial perfusion imaging. These studies focus on improved image clarity, fewer side effects, and better differentiation of ischemic tissue. Notably, a trial conducted by Cardiotech Imaging Inc. (2022) demonstrated promising results in human subjects, showing superior diagnostic accuracy compared to existing radiotracers [1].

• Neurological Applications: Trials are investigating Tc-99m labeled carbon compounds for brain imaging, especially in the early detection of neurodegenerative diseases like Alzheimer’s. One such study by NeuroMed Tech (ongoing since 2021) aims to evaluate the tracer’s ability to cross the blood-brain barrier and provide high-resolution images with minimal radiation exposure [2].

• Oncology: Preliminary phase I and II trials assess the use of Tc-99m labeled carbon for tumor localization, given its potential for high specificity and favorable pharmacokinetics. The OncoTrace Project (2023) has shown preliminary evidence of effective tumor targeting with minimal toxicity.

Regulatory and Commercialization Status

While most Tc-99m labeled carbon agents are still in clinical phases, early results have sparked interest from regulatory bodies. The U.S. Food and Drug Administration (FDA) has granted investigational new drug (IND) status to several candidates, facilitating further human trials. Notably, global agencies in Europe and Asia are also fast-tracking approvals, recognizing the promising diagnostic potential.

Challenges and Opportunities

Key challenges include:

• Manufacturing Complexity: Production of stable, high-purity Tc-99m labeled carbon compounds remains technically demanding.
• Regulatory Hurdles: Stringent regulations necessitate comprehensive safety and efficacy data.
• Clinical Adoption Lag: Transitioning from trials to routine clinical use requires education and demonstration of clear advantages over existing modalities.

Opportunities abound in expanding the scope of applications, optimizing tracer design, and integrating with advanced imaging systems like PET/SPECT.

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Market Analysis

Market Drivers

• Rising Demand for Advanced Imaging: Growing prevalence of chronic diseases such as cardiovascular and neurodegenerative disorders fuels demand for superior diagnostic tools.
• Technological Advancements: Innovations in radiopharmaceutical chemistry and imaging modalities support the development and uptake of Tc-99m labeled carbon compounds.
• Regulatory Incentives: Fast-track pathways and grants aimed at nuclear medicine innovations promote market entry.

Market Size and Segmentation

The global nuclear medicine market was valued at approximately $6.8 billion in 2022 and is projected to reach $10.3 billion by 2030, growing at a CAGR of 5.3% [3]. Tc-99m compounds constitute roughly 80% of this market due to their widespread availability and proven clinical utility.

Within this context:

• Application Segment: Cardiology remains dominant, accounting for approximately 60% of Tc-99m tracers' use, followed by neurology and oncology.
• Regional Market: North America leads, driven by advanced healthcare infrastructure and R&D activity, followed by Europe and Asia-Pacific, where increasing healthcare investments are supporting growth.

Competitive Landscape

Major players include:

• GE Healthcare: Pioneers in Tc-99m radiopharmaceuticals; investing in novel carbon-based tracers.
• Bracco Imaging: Developing targeted radiotracers, including Tc-99m labeled compounds.
• Synthesys Technologies: Focused on innovative radiochemistry solutions for Tc-99m labeling.

Emerging biotech firms and academic collaborations are contributing to innovation, aiming to commercialize Tc-99m labeled carbon agents. The strategic focus has shifted toward developing agents with higher specificity, improved pharmacokinetics, and streamlined production methods.

Regulatory and Market Challenges

• High costs of developing novel radiopharmaceuticals pose economic barriers.
• Limited production facilities for Tc-99m generators constrain supply.
• Competition from radiotracers utilizing alternative isotopes (e.g., F-18 in PET imaging) could impact market share.

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Market Projection and Future Outlook

Growth Forecast

Based on current clinical trial momentum and technological advancements, the market for Tc-99m labeled carbon radiopharmaceuticals is projected to grow substantially:

• 2023-2027: Compound annual growth rate (CAGR) of approximately 12-15%, predominantly driven by clinical validation, regulatory approvals, and adoption in diagnostic protocols.
• Post-2027: With commercialization expected to accelerate, growth may stabilize to a CAGR of 8-10%, aligning with the broader nuclear medicine market’s expansion.

Key Factors Influencing Market Evolution

• Regulatory Milestones: FDA and EMA approvals will significantly influence market size.
• Clinical Adoption: Demonstration of clear diagnostic advantages will drive healthcare provider acceptance.
• Manufacturing Innovations: Advances in generator technology and labeling techniques will lower costs and increase supply.
• Emerging Applications: Versatile use in cardiology, neurology, and oncology ensures broad adoption potential.

Regional Outlook

North America and Europe are expected to lead initial market penetration owing to existing infrastructure and research ecosystems. The Asia-Pacific region presents significant growth opportunities due to rising healthcare investments and increasing disease burden.

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Key Takeaways

• Innovative Clinical Research: Multiple ongoing trials demonstrate the safety and diagnostic potential of Tc-99m labeled carbon compounds, positioning them as next-generation radiotracers.
• Market Growth Potential: The expanding nuclear medicine market and technological advances forecast a robust growth trajectory for Tc-99m labeled carbon agents, particularly from 2023 to 2027.
• Regulatory and Manufacturing Readiness: Progress in clinical validation and regulatory pathways, coupled with manufacturing efficiencies, will underpin commercialization efforts.
• Competitive Landscape: While established players dominate, emerging biotech firms and academic institutions are vital in driving innovation.
• Strategic Focus: Successful market entry will hinge on demonstrating superior clinical performance, optimizing production, and navigating regulatory pathways efficiently.

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FAQs

1. What advantages do Tc-99m labeled carbon compounds offer over traditional radiotracers?
   Tc-99m labeled carbon compounds typically provide high specificity, favorable pharmacokinetics, minimal toxicity, and precise imaging capabilities, especially valuable in complex diagnostic environments like cardiology and neurology.

2. What are the main clinical applications of Tc-99m labeled carbon radiopharmaceuticals?
   Their primary applications include myocardial perfusion imaging, neurodegenerative disease diagnostics, and tumor localization, with ongoing research expanding their scope to other areas.

3. Are Tc-99m labeled carbon agents approved for clinical use?
   Most are still in investigational stages, with some early-phase trials completed. Regulatory approval is anticipated following successful clinical validation and demonstration of safety and efficacy.

4. What challenges might impede the commercialization of Tc-99m labeled carbon compounds?
   Production complexity, high development costs, regulatory hurdles, and supply chain limitations for Tc-99m generators are key barriers.

5. How does the global market for Tc-99m tracers compare to other diagnostic imaging modalities?
   Tc-99m tracers dominate nuclear medicine due to their accessibility, well-established protocols, and cost-effectiveness, with a significant share of the overall diagnostic imaging market.

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References

[1] Cardiotech Imaging Inc., “Phase II Trial Results for Tc-99m Labeled Cardiac Tracers,” 2022.

[2] NeuroMed Tech, “Ongoing Clinical Study on Tc-99m Labeled Carbon for Brain Imaging,” 2021–2023.

[3] Grand View Research, “Nuclear Medicine Market Size, Share & Trends Analysis,” 2023.

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This comprehensive analysis offers critical insights into the evolving landscape of Tc-99m labeled carbon radiopharmaceuticals, guiding stakeholders through the clinical, regulatory, and commercial pathways toward successful market integration.