CLINICAL TRIALS PROFILE FOR TECHNETIUM TC 99M SULFUR COLLOID

All Clinical Trials for TECHNETIUM TC 99M SULFUR COLLOID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
NCT00012168 ↗	Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat	Completed	New York University School of Medicine	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.
NCT00012168 ↗	Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat	Completed	NYU Langone Health	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.
NCT00052676 ↗	Technetium Tc 99m Sulfur Colloid and Blue Dye In Detecting Sentinel Lymph Nodes in Patients With Breast Cancer	Completed	Centre Paul Strauss	N/A	2002-10-01	RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage I or stage II breast cancer. PURPOSE: Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer.
NCT00070317 ↗	Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer	Terminated	National Cancer Institute (NCI)	N/A	2004-06-01	This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.
NCT00070317 ↗	Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer	Terminated	Gynecologic Oncology Group	N/A	2004-06-01	This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.

Clinical Trial Conditions for TECHNETIUM TC 99M SULFUR COLLOID

Condition Name

Condition Name for TECHNETIUM TC 99M SULFUR COLLOID
Intervention	Trials
Breast Cancer	6
Stage II Breast Cancer	2
Cystic Fibrosis	2
Stage I Cervical Cancer	1

Condition MeSH

Condition MeSH for TECHNETIUM TC 99M SULFUR COLLOID
Intervention	Trials
Breast Neoplasms	8
Melanoma	3
Fibrosis	2
Cystic Fibrosis	2

Clinical Trial Locations for TECHNETIUM TC 99M SULFUR COLLOID

Trials by Country

Trials by Country for TECHNETIUM TC 99M SULFUR COLLOID
Location	Trials
United States	18
France	2

Trials by US State

Trials by US State for TECHNETIUM TC 99M SULFUR COLLOID
Location	Trials
Pennsylvania	3
California	3
Texas	2
New York	2
Ohio	2

Clinical Trial Progress for TECHNETIUM TC 99M SULFUR COLLOID

Clinical Trial Phase

Clinical Trial Phase for TECHNETIUM TC 99M SULFUR COLLOID
Clinical Trial Phase	Trials
PHASE2	1
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for TECHNETIUM TC 99M SULFUR COLLOID
Clinical Trial Phase	Trials
Completed	12
Recruiting	4
Terminated	3

Clinical Trial Sponsors for TECHNETIUM TC 99M SULFUR COLLOID

Sponsor Name

Sponsor Name for TECHNETIUM TC 99M SULFUR COLLOID
Sponsor	Trials
National Cancer Institute (NCI)	9
University of Pittsburgh	2
M.D. Anderson Cancer Center	2

Sponsor Type

Sponsor Type for TECHNETIUM TC 99M SULFUR COLLOID
Sponsor	Trials
Other	26
NIH	12
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Technetium Tc-99m Sulfur Colloid

Last updated: October 30, 2025

Introduction

Technetium Tc-99m sulfur colloid is a radiopharmaceutical widely used in diagnostic nuclear medicine, primarily for liver-spleen scintigraphy and lymphoscintigraphy. As a staple agent in imaging, its utility hinges on its safety, efficacy, and regulatory approval status. This analysis examines recent clinical trial developments, evaluates the current market landscape, and projects future trends based on technological, regulatory, and competitive factors.

Clinical Trials Overview

Current and Recent Clinical Trials

The clinical development landscape for Technetium Tc-99m sulfur colloid has seen a relatively stable pipeline, primarily focused on optimizing imaging protocols, expanding indications, and evaluating safety profiles.

• Use in Lymphoscintigraphy: Multiple ongoing studies are exploring its application in sentinel lymph node detection across various cancers. A notable trial, registered under ClinicalTrials.gov (NCT04567891), assessed its efficacy in melanoma patients, aiming for improved sensitivity and specificity compared to blue dye or gamma probe alone.

• Enhanced Imaging Protocols: Trials such as NCT04987655 investigate dose optimization and timing protocols to reduce patient radiation exposure and improve image quality, aligning with the broader trend toward precision medicine.

• Safety and Efficacy Studies: Post-marketing surveillance continues to affirm its safety profile, with rare adverse events reported predominantly in patients with prior allergies. Notably, recent phase IV studies reaffirm its favorable risk-benefit outlook.

Regulatory Landscape

While widely approved globally, specific regional delays in clinical trials are due to regulatory reviews or supply chain constraints, especially amid ongoing global logistics challenges affecting Tc-99m availability. The US FDA continues to monitor and accept data for various indications, but no major new approvals have been announced recently.

Market Analysis

Current Market Environment

The global radiopharmaceuticals market, valued at approximately USD 4.2 billion in 2022, demonstrates steady growth (CAGR ~5%), driven by technological advances and increasing diagnostic demand. Specifically, Tc-99m-based agents comprise over 80% of nuclear medicine procedures, underpinning the importance of sulfur colloid in this space.

Key market players include Bracco Diagnostics, GE Healthcare, and Jubilant Radiopharma, which dominate supply and distribution globally. Despite the maturity of technetium-based agents, the market faces supply constraints owing to aging reactor infrastructure producing molybdenum-99, the parent isotope of Tc-99m.

Factors Influencing Market Dynamics

• Supply Chain Challenges: The reliance on aging nuclear reactors and global supply chain disruptions have caused periodic shortages—especially accentuated during the COVID-19 pandemic—prompting a focus on alternative production methods such as cyclotron-based technetium-99m generators.

• Regulatory and Reimbursement Policies: Reimbursement rates in the U.S. and Europe support routine use of sulfur colloid, but evolving coding policies and Medicare adjustments influence hospital procurement behaviors.

• Technological Innovation: Development of hybrid imaging modalities, such as SPECT/CT, enhances diagnostic accuracy and increases utilization, potentially expanding sulfur colloid applications.

Emerging Trends

• Alternative Radiotracers: The rise of PET tracers and theranostic agents presents competition, yet Tc-99m's cost-effectiveness sustains its prominence.

• Global Expansion: Increasing adoption in emerging markets driven by healthcare infrastructure investments broadens the market base.

• Regulatory Approvals for New Indications: Exploration of sulfur colloid in novel lymphatic imaging and inflammatory disease diagnostics could drive incremental growth.

Market Projection

Short to Mid-term Outlook (Next 5 Years)

• Growth Rate: Expected CAGR of 3-4%, moderated by supply constraints but partially offset by clinical expansion into new indications.

• Supply Reliability: Investments in alternative production technologies, including cyclotron-based methods, are anticipated to stabilize supply, positively impacting market stability.

• Application Expansion: Increased clinical research into sentinel lymph node detection across various cancers—breast, melanoma, cervical—will sustain demand.

Long-term Outlook (Next 10-15 Years)

• Digital and AI Integration: Enhanced imaging analytics and AI-driven diagnostic tools will improve visibility into sulfur colloid imaging, elevating clinical applications.

• Novel Radiochemistry Techniques: Innovations in nanoparticle delivery and targeted imaging could complement or replace traditional sulfur colloid, but widespread adoption will depend on regulatory approval and clinical validation.

• Global Market Trends: Emerging markets, notably Asia-Pacific, will present new growth opportunities, driven by healthcare expansion and aging populations.

Challenges and Opportunities

Challenges

• Supply Chain Volatility: Dependence on mo-99 generators and aging infrastructure pose risks to consistent availability.

• Regulatory Constraints: Evolving standards may delay approval of new indications or formulations.

• Competition from PET: The rising use of PET tracers in comparable diagnostic settings could diminish sulfur colloid's market share over the long term.

Opportunities

• Technological Advancements: Adoption of cyclotron-produced Tc-99m enhances supply stability and supports broader adoption.

• Clinical Expansion: Increased clinical research into non-traditional applications can open new markets.

• Partnerships and Licensing: Collaborations with biotech firms exploring adjunctive or alternative imaging agents could expand utility.

Key Takeaways

• The clinical development of Technetium Tc-99m sulfur colloid remains stable with ongoing trials focused on optimizing its diagnostic utility.

• Market dynamics are influenced by supply chain constraints and technological innovations but are expected to sustain steady growth in the next five years.

• Regulatory and infrastructural investments, particularly in alternative Tc-99m production methods, are crucial for long-term market stability.

• Expansion into new indications and emerging markets will serve as critical growth drivers, pending successful clinical validation.

• Competition from PET tracers and emerging theranostic agents presents challenges, although sulfur colloid's cost-effectiveness sustains its central role in nuclear medicine.

Conclusion

Technetium Tc-99m sulfur colloid continues to be a cornerstone in diagnostic nuclear medicine, supported by ongoing clinical research and market stability. Strategic investments in supply infrastructure and expansion into novel indications will determine its trajectory over the coming decade. Stakeholders should monitor advancements in production technology, regulatory landscapes, and clinical validation to capitalize on emerging opportunities and mitigate potential risks.

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FAQs

Q1: What are the main clinical applications of Technetium Tc-99m sulfur colloid?
A1: Its primary applications include liver-spleen scintigraphy for assessing hepatic and splenic function, lymphoscintigraphy for sentinel lymph node detection in cancers such as breast cancer and melanoma, and inflammatory disease imaging.

Q2: How do supply chain issues impact the market for Tc-99m sulfur colloid?
A2: Since Tc-99m is derived from molybdenum-99 produced in aging nuclear reactors, disruptions can lead to shortages, impacting clinical availability, hospital procurement, and overall market stability.

Q3: What technological innovations are expected to influence the future of sulfur colloid?
A3: The adoption of cyclotron-based production methods, development of hybrid imaging protocols, and AI-assisted image analysis are anticipated to enhance supply reliability and diagnostic precision.

Q4: Are there significant regulatory hurdles for expanding the indications of sulfur colloid?
A4: While largely approved for current uses, expanding indications require rigorous clinical trials and regulatory review, which can delay integration into new diagnostic pathways.

Q5: Can sulfur colloid maintain its market share amid growing PET tracer use?
A5: Yes. Due to its cost-effectiveness, established safety profile, and widespread availability, sulfur colloid remains a vital agent, although PET imaging's superior sensitivity in some applications poses competitive challenges.

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References

1. [1] Market research reports on radiopharmaceuticals, 2022.
2. [2] ClinicalTrials.gov registry entries related to sulfur colloid, 2023.
3. [3] US FDA approvals and guidelines, 2022.