CLINICAL TRIALS PROFILE FOR CARDIOLITE

All Clinical Trials for CARDIOLITE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00069160 ↗	Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2003-09-01	The purpose of this study is three-fold: 1) to examine the ability of the experimental drug tariquidar to improve chemotherapy results by blocking a protein (P-glycoprotein) on some cancer cells that acts to pump out cancer drugs; 2) examine how tariquidar interacts with the cancer drug docetaxel; and 3) evaluate the effectiveness of combination treatment with tariquidar and docetaxel in treating patients with lung, ovarian, or cervical cancer. Patients 18 years of age and older with recurrent or metastatic (spreading) lung, cervical, or ovarian cancer who cannot benefit from any standard treatment may be eligible for this study. Candidates will be screened with a medical history and physical examination; review of pathology slides; blood and urine tests; imaging tests, including computed tomography (CT) or magnetic resonance imaging (MRI) scans; chest x-ray, electrocardiogram (EKG); and possibly echocardiogram. Participants will undergo the following tests and procedures: Blood draw. Blood is drawn before treatment begins to establish baseline levels for future blood tests. Blood counts are done twice weekly after chemotherapy begins. Central venous catheter placement. A plastic tube is put into a major vein in the chest. It is used to give the study drugs or other medications, including antibiotics and blood transfusions, if needed, and to withdraw blood samples. The line is usually placed under local anesthesia in the radiology department or the operating room. It can stay in the body for months or be removed after each treatment is completed. Chemotherapy. Treatment cycles are 21 days. Both drugs are given on day 1 of each cycle. First, tariquidar is given as a 30-minute infusion. One hour after the tariquidar infusion, docetaxel is infused over 1 hour. (For the first cycle only, docetaxel is given in divided doses one week apart and tariquidar is administered on either day 1 or day 8. The order of tariquidar administration is randomized to generate optimal pharmacokinetic data. Patients will be hospitalized for several days during this cycle to gather research data). The tariquidar dose remains the same throughout the study. Docetaxel may be increased or decreased from cycle to cycle, based on side effects.
NCT00162032 ↗	A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease	Completed	Lantheus Medical Imaging	Phase 3	2005-08-01	Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.
NCT00162045 ↗	A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects	Completed	Lantheus Medical Imaging	Phase 1/Phase 2	2005-01-01	The purpose of this Phase I-II multicenter clinical trial is to establish dosimetry and safety profiles for CARDIOLITE® (Technetium Tc99m Sestamibi) in pediatric subjects.
NCT00162331 ↗	CARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI	Completed	Lantheus Medical Imaging	Phase 4	2005-01-01	The purpose of this clinical study is to learn if there are any changes in how blood gets to your heart muscle and if your heart size changed after your heart attack.
NCT00162357 ↗	Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty	Completed	Lantheus Medical Imaging	Phase 4	2004-04-01	The purpose of this clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with Cardiolite.
NCT00620373 ↗	Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts	Completed	Susan G. Komen Breast Cancer Foundation	N/A	2005-08-01	We aim to compare the sensitivity of mammography to the sensitivity of Molecular Breast Imaging (a new gamma-camera based breast imaging technology) in women with dense breast tissue who are at increased risk for breast cancer.
NCT00620373 ↗	Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts	Completed	Mayo Clinic	N/A	2005-08-01	We aim to compare the sensitivity of mammography to the sensitivity of Molecular Breast Imaging (a new gamma-camera based breast imaging technology) in women with dense breast tissue who are at increased risk for breast cancer.

Clinical Trial Conditions for CARDIOLITE

Condition Name

Condition Name for CARDIOLITE
Intervention	Trials
Breast Cancer	3
Kawasaki Disease	2
Lung Neoplasms	1
Malignant Neoplasm of Breast	1

Condition MeSH

Condition MeSH for CARDIOLITE
Intervention	Trials
Breast Neoplasms	3
Neoplasms	2
Mucocutaneous Lymph Node Syndrome	2
Coronary Artery Disease	1

Clinical Trial Locations for CARDIOLITE

Trials by Country

Trials by Country for CARDIOLITE
Location	Trials
United States	47
Canada	6
Brazil	2
Taiwan	2
Puerto Rico	1

Trials by US State

Trials by US State for CARDIOLITE
Location	Trials
Massachusetts	3
Minnesota	3
Wisconsin	3
Washington	3
Illinois	2

Clinical Trial Progress for CARDIOLITE

Clinical Trial Phase

Clinical Trial Phase for CARDIOLITE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for CARDIOLITE
Clinical Trial Phase	Trials
Completed	9
Recruiting	1

Clinical Trial Sponsors for CARDIOLITE

Sponsor Name

Sponsor Name for CARDIOLITE
Sponsor	Trials
Lantheus Medical Imaging	4
Mayo Clinic	3
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for CARDIOLITE
Sponsor	Trials
Industry	6
Other	6
NIH	4

CARDIOLITE Market Analysis and Financial Projection

Last updated: April 28, 2026

Cardiolite (Technetium Tc-99m Sestamibi): Clinical Trials Update, Market Analysis, and Projection

What is Cardiolite and how is it used?

Cardiolite is a brand of technetium Tc-99m sestamibi, a radiopharmaceutical used primarily for myocardial perfusion imaging (MPI) and related cardiac imaging applications. It is administered as an intravenous injection and imaging is performed after tracer distribution in the myocardium.

Regulatory status baseline (US): Cardiolite is an established product; the commercial footprint relies on ongoing imaging demand and radiopharmacy supply continuity rather than late-stage platform innovation. (Sources: US prescribing information and FDA product labeling.) [1][2]

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What is the clinical trials update for Cardiolite (Tc-99m sestamibi)?

No meaningful late-stage clinical development “update” exists for Cardiolite as a distinct innovation program in recent years based on public trial registries and the established nature of technetium Tc-99m sestamibi as a long-standing diagnostic agent. In practice, clinical activity in this space is dominated by:

• label-expansion or imaging protocol studies (often not materially changing the active ingredient)
• comparative imaging workflow studies (dose, timing, SPECT camera workflows)
• radiopharmacy operational research (kit handling, stability, automation)

Implication for decision-making: For investors and R&D planners, the driver of Cardiolite’s near-term value is not a new phase program, but reimbursement, imaging volumes, and product supply continuity in the technetium-radiopharmaceutical chain.

Clinical trials visibility (typical pattern for established radiopharmaceuticals):

• Trial registration activity often reflects non-inferiority imaging performance and protocol optimization rather than new therapeutic endpoints.
• Studies frequently involve imaging methodology rather than the composition change of the injectable product.

Because the product’s core active ingredient is mature and widely used, any “clinical trials update” that materially affects economics would likely show up first as a regulatory label change or a major evidence shift in payer reimbursement. Public sources do not show such a shift as a recent Cardiolite-specific milestone. (Sources: FDA labeling and product history.) [1][2]

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What does the market look like for Tc-99m sestamibi and Cardiolite?

Demand drivers

Cardiolite demand tracks the global workload of nuclear cardiology:

• evaluation of suspected coronary artery disease using MPI
• assessment of ischemia and viability
• pre-procedural and follow-up imaging in established CAD pathways

Key market drivers:

1. Cardiology imaging utilization across outpatient and hospital settings.
2. Radiopharmaceutical supply chain continuity tied to cyclotron and generator availability for technetium.
3. Payer reimbursement and imaging guideline adoption for MPI.

Supply chain and product economics

Technetium Tc-99m products face recurring operational and regulatory constraints:

• reliance on Tc-99m generator production and logistics
• radiopharmacy distribution capacity and cold-chain controls
• regulatory requirements for preparation, dispensing, and quality controls

Cardiolite’s competitive position is shaped less by clinical superiority and more by:

• reliable supply at radiopharm scale
• channel relationships (hospitals, imaging centers, distributors)
• ability to meet local regulatory expectations for compounded or prepared radiopharmaceutical workflows

Competitive set

Cardiolite sits in a crowded MPI radiopharmaceutical landscape, where the substitution set includes:

• alternative MPI tracers (including agents with different imaging kinetics and workflow needs)
• generics/authorized equivalents depending on market and regulatory regime

The presence of multiple MPI options tends to compress price growth and increases the strategic importance of:

• contracting and formularies
• inventory and supply reliability
• payer-specific preferences (site of service and reimbursement policies)

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How big is the Cardiolite market and what is the forward projection?

A clean “Cardiolite-only” market size is rarely reported as a standalone category. Industry-level reporting typically aggregates technetium-based MPI radiopharmaceuticals and myocardial perfusion imaging agents. The practical projection for Cardiolite therefore uses a top-down approach:

Projection model (business logic):

• Imaging volume growth: correlated with cardiology utilization trends and hospital outpatient migration
• Price trajectory: typically constrained by generics, competition, and reimbursement pressure
• Technetium supply risk: introduces periodic volume and distribution variability
• Utilization shifts: modality substitution (SPECT vs PET) can reduce or redirect growth in certain regions

Base-case directional outlook (2026 to 2031):

• Volume: low-to-moderate growth in most markets where SPECT MPI remains a core diagnostic pathway.
• Price: flattish to modestly declining in competitive geographies; contracting offsets list-price effects.
• Net revenue: modest growth driven by volume, not by a step-change in clinical differentiation.

Scenario ranges (revenue impact, directional):

• Bear case: reimbursement pressure and modality substitution dampen MPI growth; supply disruptions constrain distribution.
• Base case: continued demand for SPECT MPI with stable reimbursement; occasional supply volatility smooths out.
• Bull case: guideline adherence and imaging capacity expansion increase MPI utilization; supply stability improves fill rates and reduces lost distribution.

Because Cardiolite is an established Tc-99m sestamibi product, projections should be treated as market utilization and contracting-driven, not as “trial-driven growth.”

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What should investors and operators watch next?

1) Label stability and regulatory posture

Cardiolite’s near-term value depends on maintenance of existing labeling and supply compliance rather than new clinical evidence. Monitoring:

• FDA label updates and safety communications
• manufacturing site changes and supply continuity announcements
• radiopharmaceutical chain constraints that affect availability

(Primary sources: FDA labeling.) [1][2]

2) Reimbursement and imaging utilization

Key economic signal:

• changes in reimbursement for SPECT MPI and imaging-related diagnostic pathways
• payer edits impacting coverage for cardiac diagnostic workups

3) Technetium supply continuity

Tc-99m generator and logistics performance determines:

• ability to meet hospital demand
• fill-rate stability and opportunity loss during shortfalls

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Market projection table (business-ready, scenario logic)

Timeframe	Volume trend (MPI demand)	Net price trend (competition + contracting)	Net revenue trend for Cardiolite (directional)	Main drivers
2026	Low-moderate growth	Flat to modest decline	Modest growth	Persistent MPI utilization; substitution pressure
2027-2028	Low growth with variability	Flat to modest decline	Low single-digit growth	Payer policy stability; supply continuity
2029-2031	Slow growth or plateau risk	Flat to slightly down	Near-flat to modest growth	PET migration; guideline inertia; regional reimbursement

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What are the key strategic implications for R&D and commercial teams?

If you are pursuing R&D

For established Tc-99m sestamibi platforms, R&D options that can create measurable value usually target:

• imaging workflow improvements (dose reduction, timing optimization, acquisition protocols)
• device integration or SPECT workflow improvements that reduce turnaround time
• stability and preparation optimization to support radiopharmacy operations

The bar for “clinical trials update” value is high: incremental imaging protocol benefits must map to payer acceptance and radiology workflow economics.

If you are investing commercially

Revenue resilience typically comes from:

• supply chain reliability and contracting execution
• payer and provider formulary placement
• reducing lost orders due to availability issues

Because differentiation is limited once active ingredient is mature, competitive advantage often concentrates in availability, service level, and contracting.

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Key Takeaways

• Cardiolite (technetium Tc-99m sestamibi) is an established myocardial perfusion imaging radiopharmaceutical; recent “clinical trial updates” are generally protocol-level and do not typically reshape the product economics. [1][2]
• Market outcomes for Cardiolite track broader SPECT MPI utilization, payer reimbursement, and technetium supply continuity rather than late-stage innovation.
• Forward projections should be modeled around low-to-modest volume growth with price constrained by competition and contracting; net revenue is expected to be near-flat to modest growth across 2026 to 2031 in directional terms.

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FAQs

1. Does Cardiolite have new phase 3 development activity driving growth?
   Public signals for Cardiolite-specific late-stage programs are not the principal driver of near-term economics; the product remains an established Tc-99m sestamibi MPI tracer. [1][2]

2. What has the biggest impact on Cardiolite revenue in the next 3 to 5 years?
   MPI utilization trends, reimbursement coverage, and technetium supply continuity.

3. Is Cardiolite’s market uniquely large versus other Tc-99m MPI agents?
   Standalone “Cardiolite-only” sizing is not commonly reported; demand is typically aggregated across technetium-based MPI tracers.

4. Does PET substitution materially threaten Cardiolite?
   It can pressure growth rates in regions where PET adoption accelerates, but it does not eliminate SPECT MPI demand in routine diagnostic pathways.

5. What operational risk most affects availability?
   Technetium generator and logistics constraints that affect radiopharmacy fulfillment and fill rates.

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References

[1] U.S. Food and Drug Administration. Cardiolite (technetium tc 99m sestamibi) prescribing information / product labeling. FDA.
[2] U.S. Food and Drug Administration. Drug Trials Snapshots and FDA-approved product information for Cardiolite (technetium tc 99m sestamibi). FDA.