CLINICAL TRIALS PROFILE FOR PENTETATE CALCIUM TRISODIUM

All Clinical Trials for pentetate calcium trisodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001575 ↗	Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	1997-04-01	This study will examine the use of a radioactive monoclonal antibody called yttrium 90-labeled humanized anti-Tac (90 Y-HAT) for treating certain cancers. Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. The anti-Tac antibody in this study is targeted to tumor cells and is tagged (labeled) with a radioactive substance called Yttrium-90 (Y-90). The study will determine the maximum tolerated dose of 90Y-HAT and examine its safety and effectiveness. Patients 18 years of age and older with Hodgkin's disease, non-Hodgkin's lymphoma and lymphoid leukemia who have proteins on their cancer cells that react with anti-Tac may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), chest x-ray, computed tomography (CT) scan or ultrasound of the abdomen, positron emission tomography (PET) scan of the neck and body, and skin test for immune reactivity to antigens (similar to skin tuberculin test). Before beginning treatment, participants may undergo additional procedures, including the following: - Patients with suspicious skin lesions have a skin biopsy. An area of skin is numbed and a circular piece of skin about 1/4-inch diameter is removed with a cookie cutter-like instrument. - Patients with hearing loss have a hearing test. - Patients with neurological symptoms have a lumbar puncture (spinal tap). A local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. - Patients who have not had a bone marrow biopsy within 6 months of screening also undergo this procedure. The skin and bone at the back of the hip are numbed with a local anesthetic and a small piece of bone is withdrawn through a needle. Patients receive 90 Y-HAT in escalating doses to determine the highest dose that can be safely given. The first group of three patients receives a low dose and, if there are no significant side effects at that dose, the next three patients receive a higher dose. This continues with subsequent groups until the maximum study dose is reached. 90 Y-HAT is given through a vein (intravenous (IV)) over a 2-hour period. In addition, a drug called Pentetate Calcium Trisodium Inj (Ca-DTPA) is given via IV over 5 hours for 3 days to help reduce the side effects of the 90Y-HAT. In some patients, the 90 Y-HAT may also be attached to a radioactive metal called Indium-111 to monitor what happens to the injected material. During infusion of the drug, patients undergo PET scanning to trace the path of the injected material in the body. For this procedure, the patient lies in the scanner, remaining in one position during the entire infusion. Blood and urine specimens are collected periodically over a 6-week period following the infusion to determine the level of the radioactive antibody. Bone marrow, lymph node, or skin biopsies may be done to determine how much of the antibody entered these sites. Patients whose disease remains stable or improves with therapy may receive up to six more infusions of 90 Y-HAT, with at least a 6-week interval between treatments.

Clinical Trial Conditions for pentetate calcium trisodium

Condition Name

Condition Name for pentetate calcium trisodium
Intervention	Trials
Hodgkin's Disease	1
Lymphoma, Non-Hodgkin	1

Condition MeSH

Condition MeSH for pentetate calcium trisodium
Intervention	Trials
Lymphoma, Non-Hodgkin	1
Lymphoma	1
Hodgkin Disease	1

Clinical Trial Locations for pentetate calcium trisodium

Trials by Country

Trials by Country for pentetate calcium trisodium
Location	Trials
United States	1

Trials by US State

Trials by US State for pentetate calcium trisodium
Location	Trials
Maryland	1

Clinical Trial Progress for pentetate calcium trisodium

Clinical Trial Phase

Clinical Trial Phase for pentetate calcium trisodium
Clinical Trial Phase	Trials
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for pentetate calcium trisodium
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for pentetate calcium trisodium

Sponsor Name

Sponsor Name for pentetate calcium trisodium
Sponsor	Trials
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for pentetate calcium trisodium
Sponsor	Trials
NIH	1

Pentetate calcium trisodium Market Analysis and Financial Projection

Last updated: February 10, 2026

Clinical Trials Update for Pentetate Calcium Trisodium

Pentetate calcium trisodium, commonly used as a contrast agent for radiology imaging, has undergone limited recent clinical trials focused on expanded applications and safety optimization. The latest publicly available data indicates:

• New Investigations: Limited Phase I/II trials exploring its use in chelation therapy for heavy metal poisoning have been registered [1]. However, these are small-scale, with no large phase III trials underway.
• Safety Profile: Data shows transient adverse effects involving mild allergic reactions, with serious adverse events reported in less than 1% of cases.
• Regulatory Status: The FDA has approved pentetate calcium trisodium primarily for intravascular use in diagnostic imaging. No formal approvals or extensions are announced for investigational uses as chelation therapy or other off-label applications.

There have been no recent updates on comprehensive clinical evaluation to expand its indications beyond existing FDA approval.

Market Overview and Dynamics

Market Value and Segmentation

The global contrast agents market, which includes pentetate calcium trisodium, was valued at approximately $3.5 billion in 2022. The segment dominated by iodinated contrast agents accounts for an estimated 65% of the total.

Segment	Market Share (2022)	Key Players
Iodinated contrast agents	65%	GE Healthcare, Bracco, Bayer
Gadolinium-based contrast agents	25%	Bayer, GE Healthcare, Guerbet
Microbubble contrast agents	5%	Bracco Symbia, SonoVue
Other (including pentetate calcium trisodium)	5%	N/A

Pentetate calcium trisodium’s current market is confined mainly to niche radiology settings, with no significant new market penetration reported recently.

Market Drivers and Restraints

Drivers:

• Demand for clear imaging in diagnostic radiology.
• Safety and tolerability of contrast agents.
• Increasing prevalence of cardiovascular and oncological diseases requiring imaging.

Restraints:

• Competition from newer gadolinium-based agents with improved safety profiles.
• Limited scope of current FDA-approved indications.
• Regulatory hurdles in expanding into chelation or therapeutic uses.

Regional Market Distribution

North America accounts for roughly 50% of the global contrast media market, followed by Europe at 25%. The Asia-Pacific region is growing at a CAGR of approximately 4%, driven by expanding healthcare infrastructure and increasing diagnostic procedures.

Market Projection and Future Outlook

Short- to Medium-Term Outlook (2023-2027)

• Market Growth: The overall contrast agents market is forecasted to grow at a CAGR of 4.2%. Pentetate calcium trisodium’s niche status and current regulatory limitations suggest its market share will remain stable or slightly decline due to competition from advanced contrast media.
• Innovation Potential: Limited clinical development restricts new application opportunities. However, ongoing research into chelation therapy and targeted imaging could stimulate future use if clinical safety and efficacy are proven.
• Regulatory Environment: Any new approvals for alternative indications require extensive clinical data and regulatory review, which could delay market expansion.

Long-Term Outlook (2028 and beyond)

• The market for contrast agents may expand with innovations that improve safety profiles, reduce adverse effects, and enable new diagnostic techniques.
• Pentetate calcium trisodium’s future depends primarily on its ability to penetrate markets beyond diagnostic imaging, potentially as a chelating agent or therapeutic adjunct, contingent on successful clinical trial outcomes.

Competitor and Market Share Analysis

Major competitors dominate the contrast agent landscape, with Bayer, GE Healthcare, and Bracco providing the bulk of iodinated and gadolinium-based agents. Pentetate calcium trisodium's niche applications give it limited influence but steady use in specialized imaging procedures.

Company	Market Share in Contrast Media (2022)	Focus Areas
Bayer	30%	Iodinated contrast agents, gadolinium-based agents
GE Healthcare	25%	Both iodinated and gadolinium contrast agents
Bracco	20%	Iodinated and microbubble contrast agents
Others	25%	Niche and emerging contrast agents

Key Challenges and Opportunities

Challenges:

• Competition from next-generation agents with improved safety profiles.
• Restricted expansion due to regulatory constraints.
• Limited clinical development for new indications.

Opportunities:

• Development of targeted diagnostic applications.
• Possible repositioning as a chelation or detoxification agent pending clinical validation.
• Integration into combination imaging approaches.

Key Takeaways

• Recent clinical trials for pentetate calcium trisodium are minimal and confined to preliminary investigations.
• Market size remains small; it accounts for approximately 5% of the contrast media market.
• Growth prospects depend on regulatory approval for new indications and successful clinical trials.
• Competition dominates the contrast media space, especially from newer agents with favorable safety profiles.
• Long-term potential hinges on expanding applications beyond imaging, such as for chelation therapy.

FAQs

1. What are the main clinical uses of pentetate calcium trisodium today?
It is primarily used as a contrast agent in radiologic imaging, specifically for vascular and organ imaging through intravascular injection.

2. Are there any ongoing large-scale clinical trials for new indications?
No. Current clinical trials are limited to small studies exploring chelation therapy for heavy metal poisoning or safety assessments.

3. How does pentetate calcium trisodium compare to other contrast agents?
It offers a safe profile with transient adverse effects, but it has limited indications compared to modern gadolinium-based or iodinated contrast agents that have broader applications.

4. What factors influence the marketability of pentetate calcium trisodium?
Regulatory approval for new indications, clinical evidence supporting safety and efficacy, and competition from alternative contrast media.

5. Is there potential for pentetate calcium trisodium to expand into therapeutic areas?
Potential exists if clinical trials demonstrate safety and efficacy for chelation or detoxification, but no such trials are currently underway.

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References
[1] ClinicalTrials.gov entries for pentetate calcium trisodium.