CLINICAL TRIALS PROFILE FOR SODIUM IODIDE I-131

All Clinical Trials for sodium iodide i-131

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00638092 ↗	A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years	Completed	National Institute for Health Research, United Kingdom	Phase 4	2010-03-01	The purpose of this trial is to determine whether iodide supplementation of neonates born under 31 weeks gestation improves neurodevelopment measured at two years of age.
NCT00638092 ↗	A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years	Completed	University of Dundee	Phase 4	2010-03-01	The purpose of this trial is to determine whether iodide supplementation of neonates born under 31 weeks gestation improves neurodevelopment measured at two years of age.
NCT00638092 ↗	A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years	Completed	University of Oxford	Phase 4	2010-03-01	The purpose of this trial is to determine whether iodide supplementation of neonates born under 31 weeks gestation improves neurodevelopment measured at two years of age.
NCT00725946 ↗	Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT	Terminated	Stanford University	Early Phase 1	2008-02-01	This is a pilot imaging study for women whose tumors express NIS [Na+I- symporter, sodium iodide symporter]. Eligibility is limited to the presence of strong (3+) and/or plasma membrane staining in > 20% of cells as determined by immunohistochemical methods. A total of 10 patients will be imaged with 124I PET/CT (serial scans over 24 hour period) to determine radioiodide uptake and distribution in tumor tissue. Thyroid iodide uptake and retention will be blocked beginning one week prior to 124I PET/CT scan with thyroid hormone (T3) and methimazole (impedes organification). Tumor, organ and whole body dosimetry will be calculated in each patient.
NCT00450814 ↗	Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2006-11-30	This phase I/II trial studies the side effects and best dose of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients with multiple myeloma that has come back (recurrent) or has not responded to previous treatment (refractory). Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vaccine therapy together with cyclophosphamide may be a better treatment for multiple myeloma.
NCT00450814 ↗	Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma	Completed	Mayo Clinic	Phase 1/Phase 2	2006-11-30	This phase I/II trial studies the side effects and best dose of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients with multiple myeloma that has come back (recurrent) or has not responded to previous treatment (refractory). Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vaccine therapy together with cyclophosphamide may be a better treatment for multiple myeloma.

Clinical Trial Conditions for sodium iodide i-131

Condition Name

Condition Name for sodium iodide i-131
Intervention	Trials
Breast Cancer	4
Recurrent Plasma Cell Myeloma	2
Refractory Plasma Cell Myeloma	2
Ovarian Endometrioid Adenocarcinoma	2

Condition MeSH

Condition MeSH for sodium iodide i-131
Intervention	Trials
Breast Neoplasms	4
Carcinoma	3
Neoplasms, Plasma Cell	3
Multiple Myeloma	3

Clinical Trial Locations for sodium iodide i-131

Trials by Country

+

−

Trials by Country for sodium iodide i-131
Location	Trials
United States	13
United Kingdom	3
Korea, Republic of	2
Canada	2
China	1

Trials by US State

+

−

Trials by US State for sodium iodide i-131
Location	Trials
Minnesota	6
Florida	2
Arizona	2
California	2
Arkansas	1

Clinical Trial Progress for sodium iodide i-131

Clinical Trial Phase

Clinical Trial Phase for sodium iodide i-131
Clinical Trial Phase	Trials
Phase 4	3
Phase 2	4
Phase 1/Phase 2	3

Clinical Trial Status

Clinical Trial Status for sodium iodide i-131
Clinical Trial Phase	Trials
Recruiting	7
Completed	4
Terminated	4

Clinical Trial Sponsors for sodium iodide i-131

Sponsor Name

Sponsor Name for sodium iodide i-131
Sponsor	Trials
Mayo Clinic	6
National Cancer Institute (NCI)	5
Stanford University	2

Sponsor Type

Sponsor Type for sodium iodide i-131
Sponsor	Trials
Other	21
NIH	5
Industry	1

Sodium Iodide I-131: Clinical Trials, Market Analysis, and Projections

Introduction to Sodium Iodide I-131

Sodium Iodide I-131 is a radiopharmaceutical widely used in nuclear medicine for diagnostic and therapeutic purposes, particularly in the management of thyroid conditions. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Applications

Diagnostic Uses

Sodium Iodide I-131 is primarily used for the radioactive iodide (RAI) uptake test to evaluate thyroid function and to localize metastases associated with thyroid malignancies. It is essential for assessing thyroid function, differentiating between hypo- and hyperthyroidism, and evaluating thyroid cancer and metastases[4].

Therapeutic Uses

In therapeutic contexts, Sodium Iodide I-131 is used to treat hyperthyroidism and certain types of thyroid cancer. It has also shown promise in gene therapy strategies, particularly in non-thyroidal tumors, where the sodium iodide symporter (NIS) gene is transferred to enable radioiodine accumulation and subsequent tumor reduction[1].

Ongoing and Completed Trials

Several clinical trials have explored the efficacy and safety of Sodium Iodide I-131 in various settings. For instance, a phase 1 trial involving the use of the measles virus expressing the NIS gene (MV-NIS) in combination with I-131 showed promising results in treating prostate cancer and myeloma. However, the uptake was modest and not seen in all lesions[1].

A phase 2 study conducted at the University of Arkansas has recently been completed, although the data has not yet been published. These trials highlight the ongoing research into the expanded use of Sodium Iodide I-131 in cancer therapy.

Market Analysis

Global Market Size and Growth

The global Sodium Iodide I-131 Kits and Capsules market was valued at US$ 239 million in 2023 and is expected to reach US$ 571 million by 2030, growing at a CAGR of 12.8% during the forecast period of 2024-2030[2].

Regional Market Distribution

The Asia-Pacific region holds the largest market share at 36%, followed by North America and Europe with shares of 29% and 27%, respectively. The market is dominated by key players such as Curium Pharma, China Isotope & Radiation Corporation (CIRC), and Jubilant Pharmova, with the top three players holding over 75% of the market share[2].

Product and Application Segments

Capsules are the largest product segment, accounting for 61% of the market. In terms of application, hyperthyroidism treatment dominates with a 95% share, while thyroid cancer treatment also constitutes a significant portion[2].

Market Drivers and Trends

Growing Demand in Medical Applications

The increasing use of sodium iodide in medical applications, particularly in diagnostic imaging and therapeutic treatments, is a key driver for the market. The demand for non-invasive diagnostic imaging techniques and the growing need for effective and less invasive treatments are driving the market forward[3].

Expansion in Emerging Markets

Emerging markets, especially in Asia-Pacific, Latin America, and Africa, are seeing significant growth due to improvements in healthcare infrastructure. This expansion is driven by increasing healthcare investments and the need for advanced diagnostic tools and therapies[3].

Technological Advancements

Advancements in nuclear medicine, including the use of Sodium Iodide I-131 in positron emission tomography (PET) and single-photon emission computed tomography (SPECT), are further enhancing the market. Government support, such as the U.S. government's allocation of USD 4.5 billion for nuclear medicine research in 2021, also plays a crucial role in driving market growth[3].

Projections and Future Outlook

Market Growth Projections

The Sodium Iodide I-131 market is expected to continue its growth trajectory, driven by increasing demand in medical applications and expanding healthcare infrastructure in emerging markets. The global Iodine-131 market, specifically, is anticipated to reach US$ 2,578.25 thousand by 2030, growing at a CAGR of 5.06% during the forecast period of 2024-2030[5].

Emerging Opportunities

The integration of Sodium Iodide I-131 in gene therapy and oncolytic virotherapy represents a promising area of research. Studies involving the NIS gene and its application in various cancers have shown significant antitumor activity, suggesting potential future applications beyond traditional thyroid treatments[1].

Challenges and Limitations

Despite the growth prospects, the market faces challenges such as the need for stringent safety protocols due to the radioactive nature of I-131. Contraindications, particularly for pregnant women, and the potential for adverse effects on the fetal thyroid gland, must be carefully managed[4].

Key Takeaways

• Clinical Trials: Ongoing and completed trials highlight the therapeutic potential of Sodium Iodide I-131 beyond traditional thyroid treatments, including gene therapy and oncolytic virotherapy.
• Market Growth: The global market is expected to grow significantly, driven by increasing demand in medical applications and expanding healthcare infrastructure.
• Regional Distribution: Asia-Pacific, North America, and Europe are the key regions driving market growth.
• Product Segments: Capsules dominate the product segment, with hyperthyroidism treatment being the primary application.
• Future Outlook: Emerging markets and technological advancements in nuclear medicine are expected to further drive market growth.

FAQs

What is the primary use of Sodium Iodide I-131 in clinical settings?

Sodium Iodide I-131 is primarily used for the radioactive iodide (RAI) uptake test to evaluate thyroid function and to treat hyperthyroidism and certain types of thyroid cancer.

Which regions dominate the Sodium Iodide I-131 market?

The Asia-Pacific region holds the largest market share, followed by North America and Europe.

What are the key drivers of the Sodium Iodide I-131 market?

The key drivers include growing demand in medical applications, expansion in emerging markets, and technological advancements in nuclear medicine.

What are the potential future applications of Sodium Iodide I-131?

Future applications include gene therapy and oncolytic virotherapy, particularly in non-thyroidal tumors.

What are the contraindications for the use of Sodium Iodide I-131?

Sodium Iodide I-131 is contraindicated for use in women who are or may become pregnant due to the potential harm to the fetal thyroid gland.

How is the global Iodine-131 market expected to grow?

The global Iodine-131 market is anticipated to reach US$ 2,578.25 thousand by 2030, growing at a CAGR of 5.06% during the forecast period of 2024-2030.

Sources

1. ERC: "The sodium iodide symporter (NIS): novel applications for cancer gene therapy and imaging" - European Journal of Endocrinology[1].
2. QYResearch: "Global Sodium Iodide I-131 Kits and Capsules Market Research Report 2024" - QYResearch[2].
3. Market.US: "Sodium Iodide Market Size, Share | CAGR of 6.2%" - Market.US[3].
4. DraxImage: "DRAXIMAGE® I-131 Diagnostic Capsules" - DraxImage[4].
5. GIIR: "Global Iodine-131 Market Research Report 2024" - GIIR[5].