CLINICAL TRIALS PROFILE FOR TECHNETIUM TC-99M ALBUMIN KIT

All Clinical Trials for Technetium Tc-99m Albumin Kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00847522 ↗	Fluorescein for Lymphatic Mapping and Sentinel Lymph Node (SLN) Biopsy in Patients With Stage I and II Malignant Melanoma	Completed	University of Utah	Phase 1/Phase 2	2009-02-01	The purpose of this research study is to use two different drugs to find where melanoma might spread and to remove these tissues. We believe that tumor cells from the melanoma first move through the lymphatic system (a system of clear fluid that moves around the body and carries white blood cells, much like the blood system) to a lymph node in an orderly way. If we can identify the first lymph nodes to receive a tumor cell, this can be removed and examined. We currently use one drug, called "technetium-99m sulfur colloid" which can detect about 90% of the first lymph nodes that the tumor cells would move to. Technetium-99m is a radioactive compound and can be detected through the skin by a special instrument that reads radioactivity. As part of this research, we would like to use a second drug called "fluorescein" (Fluorescite®) to see if it will identify the same lymph nodes or additional ones and examine these. This drug is fluorescent and can be detected even through the skin using a blue light. This drug is approved by the Federal Drug Administration (FDA) to for injection in the vein as a diagnostic aid and has been safely used in people for many years. In this study, we will be injecting it under the skin, which is a different use from how it is currently approved by the FDA. In the past another drug has been used, called "isosulfan blue" (Lymphazurin®), but availability of this drug is currently limited, and it has higher risks associated with it. This study is being conducted by Dr. Robert Andtbacka, Dr. Dirk Noyes, Dr. James McGreevy and at University of Utah. This study is a Phase I/II and is done to find out if the drug can be used safely when given under the skin and if it will work for this purpose.
NCT01982123 ↗	SPECT/CT in Measuring Lung Function in Patients With Cancer Undergoing Radiation Therapy	Completed	National Cancer Institute (NCI)	N/A	2014-01-17	This pilot clinical trial studies single photon emission computed tomography (SPECT)/computed tomography (CT) in measuring lung function in patients with cancer undergoing radiation therapy. Diagnostic procedures that measure lung function may help doctors find healthy lung tissue and allow them to plan better treatment.

Clinical Trial Conditions for Technetium Tc-99m Albumin Kit

Condition Name

Condition Name for Technetium Tc-99m Albumin Kit
Intervention	Trials
Liver Neoplasm	1
Lung Carcinoma	1
Malignant Neoplasm	1

Condition MeSH

Condition MeSH for Technetium Tc-99m Albumin Kit
Intervention	Trials
Carcinoma, Hepatocellular	3
Carcinoma	2
Lung Neoplasms	2

Clinical Trial Locations for Technetium Tc-99m Albumin Kit

Trials by Country

Trials by Country for Technetium Tc-99m Albumin Kit
Location	Trials
United States	7
United Kingdom	1
Hong Kong	1
Norway	1

Trials by US State

Trials by US State for Technetium Tc-99m Albumin Kit
Location	Trials
Washington	4
North Carolina	1
Indiana	1
Utah	1

Clinical Trial Progress for Technetium Tc-99m Albumin Kit

Clinical Trial Phase

Clinical Trial Phase for Technetium Tc-99m Albumin Kit
Clinical Trial Phase	Trials
PHASE2	2
Phase 4	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Technetium Tc-99m Albumin Kit
Clinical Trial Phase	Trials
Recruiting	3
Completed	2
ACTIVE_NOT_RECRUITING	1

Clinical Trial Sponsors for Technetium Tc-99m Albumin Kit

Sponsor Name

Sponsor Name for Technetium Tc-99m Albumin Kit
Sponsor	Trials
National Cancer Institute (NCI)	2
University of Washington	2
Hoosier Cancer Research Network	2

Sponsor Type

Sponsor Type for Technetium Tc-99m Albumin Kit
Sponsor	Trials
Other	11
Industry	3
NIH	2

Last updated: April 28, 2026

Technetium Tc-99m Albumin Kit: Clinical Trials Update, Market Analysis, and Projection

What is Technetium Tc-99m Albumin Kit and how is it used?

Technetium Tc-99m albumin kits are radiopharmaceutical cold kits that, after labeling with Tc-99m per approved instructions, produce a technetium-labeled albumin radiotracer used primarily for:

• Ventilation and perfusion imaging workflow support in nuclear medicine.
• Lung perfusion scintigraphy (commonly part of suspected pulmonary embolism pathways, depending on local clinical protocols).
• Other albumin-based nuclear medicine imaging indications that vary by jurisdiction and product label.

These kits are typically marketed and distributed as radioactive diagnostic agents through nuclear medicine supply channels and administered in imaging centers rather than used as systemic therapeutics.

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What is the current clinical trials activity for Technetium Tc-99m albumin kits?

No complete, reliable, globally comprehensive clinical trials dataset is available in the provided inputs to produce a complete and accurate “clinical trials update” by trial phase (Phase 1 to 4), status (active, recruiting, completed), or geography.

As a result, a full clinical trials update cannot be generated with the required precision (trial identifiers, dates, endpoints, and cohort sizes) without risk of inaccuracies.

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What does market demand look like for Technetium Tc-99m albumin kits?

The market for technetium-labeled albumin diagnostic kits is driven by:

• High baseline utilization of nuclear medicine imaging (especially lung imaging pathways).
• Institutional purchasing cycles for radiopharmaceutical kits.
• Regional guideline adoption for pulmonary embolism diagnostics and related imaging workflows.

Key market characteristics:

• Kit economics are supply- and label-instruction dependent, with pricing influenced by kit format, labeling yield, shelf life, and distribution model.
• Demand correlates with imaging volume, scanner availability, and reimbursement policy at the country level.
• Regulatory and pharmacovigilance requirements for radioactive diagnostic kits shape launch timing and renewal cycles.

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Who buys and administers these kits?

Purchasers and users typically include:

• Hospital nuclear medicine departments
• Imaging centers with nuclear medicine capability
• Radiopharmacy networks that prepare or coordinate labeling and administration

The “buy-side” tends to be institutional, not outpatient-driven, and procurement is often bundled into service relationships for radiopharmaceutical supply.

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How do competitive dynamics typically work?

Competitive pressure usually comes from:

• Interchangeable Tc-99m radiopharmaceutical kit substitutes used for similar imaging workflows.
• Local regulatory approvals and manufacturing continuity (cold kit stability, labeling consistency).
• Supply reliability and distribution lead times, which matter because demand is tightly tied to scheduled imaging activity.

Because Tc-99m albumin is an established radiotracer category, competition often centers on availability, compliance, and total cost per prepared dose, rather than novel clinical efficacy claims.

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What are the main risks to market growth and supply?

Commercial and operational risks include:

• Tc-99m supply chain constraints impacting availability and pricing across radiopharmaceutical categories.
• Reimbursement changes that alter imaging utilization rates.
• Regulatory action on manufacturing sites or product-specific labeling requirements.
• Potential imaging pathway shifts where alternate modalities (CT pulmonary angiography, other nuclear agents) change test selection patterns.

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How should a market projection be structured for 2025 to 2035?

A credible projection must be anchored to at least one quantitative driver (imaging volumes, radiotracer demand, or historical kit sales). In the provided inputs, no historical sales baseline, current unit volumes, or region-level adoption data is supplied.

Without that, any numeric market forecast would be non-actionable and risk being incorrect. Per constraints, a complete and accurate projection cannot be produced.

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What can be quantified from available information alone?

Only structural projection guidance can be stated, not numeric forecasts:

• Demand grows with imaging volumes (population aging, pulmonary disease prevalence, and increased access to nuclear medicine).
• Pricing is shaped by supply economics (Tc-99m availability, manufacturing capacity, and shipping/logistics).
• Unit growth is capacity-limited by radiopharmacy preparation throughput and kit availability.

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Market scenario framework (directional)

While numeric forecasts cannot be produced, scenario logic can be mapped to typical industry levers:

Upside scenario drivers

• Expansion in nuclear medicine imaging access
• Stabilization of Tc-99m supply
• Reimbursement support for lung perfusion imaging workflows

Base scenario drivers

• Mature adoption with incremental growth aligned to healthcare utilization trends
• Periodic supply tightness but manageable scheduling

Downside scenario drivers

• Tc-99m shortages or persistent cold-kit availability constraints
• Structural shifts toward alternate imaging pathways
• Reimbursement compression affecting imaging utilization

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Key Takeaways

• Technetium Tc-99m albumin kits are established nuclear medicine radiotracer cold kits used mainly for lung perfusion and related imaging workflows.
• A complete, accurate clinical trials update requires specific trial records and phase/status data that are not present in the provided inputs.
• A complete, accurate numeric market projection for 2025-2035 also requires a baseline (sales, unit volumes, or imaging-volume data) that is not present in the provided inputs.
• Practical planning should be tied to three measurable drivers: Tc-99m supply stability, reimbursement and imaging utilization patterns, and radiopharmacy preparation capacity.

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FAQs

1) Are Tc-99m albumin kits new therapeutic platforms?
No. They are established diagnostic radiopharmaceutical kits used for imaging workflows in nuclear medicine.

2) What most directly drives demand for Tc-99m albumin kits?
Imaging utilization volume and institutional procurement schedules tied to nuclear medicine services.

3) What are the biggest supply-side risks?
Tc-99m supply constraints and manufacturing or distribution disruptions that affect kit availability.

4) Why do competitors matter even when the tracer category is established?
Because substitute radiopharmaceuticals and local product availability determine which kits get procured for specific imaging protocols.

5) What is the best way to forecast the market without guessing?
Anchor forecasts to historical sales or imaging-volume data by geography, then map to Tc-99m supply and reimbursement policy changes.

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References

No sources were provided in the prompt to cite.