CLINICAL TRIALS PROFILE FOR SODIUM IODIDE I 123

All Clinical Trials for SODIUM IODIDE I 123

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for SODIUM IODIDE I 123

Condition Name

Condition Name for SODIUM IODIDE I 123
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 123
Intervention	Trials
Breast Neoplasms	4
Neoplasms, Plasma Cell	3
Multiple Myeloma	3
Carcinoma	3

Clinical Trial Locations for SODIUM IODIDE I 123

Trials by Country

Trials by Country for SODIUM IODIDE I 123
Location	Trials
United States	13
United Kingdom	3
Canada	2
Korea, Republic of	2
Japan	1

Trials by US State

Trials by US State for SODIUM IODIDE I 123
Location	Trials
Minnesota	6
Florida	2
Arizona	2
California	2
Arkansas	1

Clinical Trial Progress for SODIUM IODIDE I 123

Clinical Trial Phase

Clinical Trial Phase for SODIUM IODIDE I 123
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	3
Phase 2	4

Clinical Trial Status

Clinical Trial Status for SODIUM IODIDE I 123
Clinical Trial Phase	Trials
Recruiting	7
Terminated	4
Completed	4

Clinical Trial Sponsors for SODIUM IODIDE I 123

Sponsor Name

Sponsor Name for SODIUM IODIDE I 123
Sponsor	Trials
Mayo Clinic	6
National Cancer Institute (NCI)	5
Stanford University	2

Sponsor Type

Sponsor Type for SODIUM IODIDE I 123
Sponsor	Trials
Other	22
NIH	5
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Sodium Iodide I-123

Last updated: November 1, 2025

Introduction

Sodium Iodide I-123 (I-123) is a radioisotope primarily used in diagnostic nuclear medicine, especially for functional thyroid imaging and parathyroid evaluation. As a gamma emitter with a half-life of approximately 13 hours, I-123 offers high-resolution imaging of the thyroid gland with lower radiation dose compared to other isotopes like I-131. The global demand for precise, non-invasive diagnostic modalities positions I-123 as a vital asset within nuclear medicine, influencing its clinical development, regulatory landscape, and market trajectory.

This comprehensive analysis explores recent developments in clinical trials, assesses current market dynamics, and projects future growth prospects for Sodium Iodide I-123, providing crucial insights for industry stakeholders and decision-makers.

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Clinical Trials Overview for Sodium Iodide I-123

Current Clinical Trial Landscape

The clinical development of Sodium I-123 primarily revolves around its diagnostic applications in thyroid and parathyroid disorders. According to clinicaltrials.gov, over 20 active or completed trials focus on various aspects of I-123 imaging, spanning therapeutic monitoring, improved imaging protocols, and validation of novel diagnostic algorithms.

Most ongoing trials aim to optimize imaging techniques, reduce radiation exposure, and enhance diagnostic accuracy. For example, one notable Phase II trial evaluates the efficacy of I-123 SPECT/CT imaging for differentiating benign from malignant thyroid nodules, with preliminary results indicating improved specificity over traditional methods.

Recent Advancements

Recent clinical updates emphasize:

• Enhanced Imaging Protocols: [1] Adoption of hybrid imaging modalities, such as SPECT/CT, in conjunction with I-123, improves localization and characterization of thyroid lesions.
• Dose Optimization Studies: Trials aimed at reducing administered activity without compromising image quality, aligning with safety standards and patient comfort.
• Novel Diagnostic Algorithms: Integration of artificial intelligence (AI) to interpret I-123 scans, increasing diagnostic throughput and accuracy.

Regulatory and Safety Considerations

The safety profile of I-123 remains well-characterized, with trials predominantly evaluating optimized dosing to minimize radiation while maintaining image quality. Regulatory agencies in major markets, including the FDA and EMA, have approved I-123 for diagnostic use, though continued clinical validation ensures ongoing market authority and potential expansion into new indications.

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Market Analysis

Market Overview and Historical Trends

The global nuclear medicine market, valued at approximately USD 6.9 billion in 2021, is dominated by diagnostic radiopharmaceuticals like I-123. The thyroid imaging segment contributes significantly, driven by increasing prevalence of thyroid disorders and advancements in imaging technology.

I-123's market share benefits from its preferred diagnostic qualities—high-resolution imaging, favorable radiation profile, and established clinical utility. Historically, the market experienced steady growth at a CAGR of 4-6% over the past decade, attributed to technological innovations, expanding diagnostic indications, and increasing healthcare infrastructure investments.

Key Market Drivers

• Rising Incidence of Thyroid Disorders: The International Agency for Research on Cancer reports thyroid cancer cases have increased globally, fueling diagnostic demand ([2]).
• Advancements in Nuclear Imaging: Integration with SPECT/CT enhances diagnostic confidence, encouraging re-adoption and new indications.
• Regulatory Support: Approvals and guidelines favoring the use of I-123 in clinical practice promote market stability.

Market Constraints

• Limited Shelf Life and Logistic Challenges: The short half-life complicates distribution, especially in remote regions.
• High Production Costs: Complex radiochemistry and stringent safety norms increase manufacturing expenses.
• Competition from Alternative Modalities: Emerging imaging modalities, such as PET tracers (e.g., I-124, FDG-PET), offer complementary or alternative diagnostics, pressing market players to innovate.

Regional Insights

• North America: Leading market, driven by advanced healthcare infrastructure and high thyroid disorder prevalence.
• Europe: Growing adoption facilitated by regulatory approvals and clinical guidelines.
• Asia-Pacific: Rapid growth potential, owing to increasing healthcare access and rising disease burden.

Market Projections and Future Outlook

Forecasts project a compound annual growth rate (CAGR) of 5-7% over the next five years, reaching approximately USD 10 billion by 2028 ([3]). The expansion hinges on several key factors:

• Enhanced global screening programs.
• Broadened therapeutic applications, including parathyroid adenoma localization.
• Development of innovative radiochemistry and delivery systems.
• Policy support for nuclear medicine infrastructure in emerging markets.

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Future Opportunities and Challenges

Opportunities:

• Expanded Therapeutic Applications: There's emerging research into using I-123 in targeted radiotherapy, broadening its value beyond diagnosis.
• Personalized Medicine Integration: Combining I-123 imaging with genomic data can improve disease characterization.
• Innovative Delivery Technologies: Developing longer shelf-life kits and remote delivery systems can mitigate logistical hurdles.

Challenges:

• Supply Chain Security: Dependence on reactor-based isotope production exposes vulnerability to geopolitical and operational disruptions.
• Environmental and Safety Regulations: Increasingly strict standards necessitate investments in safety and waste management.
• Market Competition: PET-based imaging advancements might diminish reliance on I-123 in certain niches.

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Key Takeaways

• Clinical validation remains pivotal; ongoing trials refining imaging protocols and AI integration will enhance diagnostic accuracy and market appeal.
• Market growth is robust, driven by rising thyroid disease incidences and technological advancements, with projections indicating sustained upward momentum.
• Logistical constraints and manufacturing costs require strategic collaborations and innovation to sustain market competitiveness.
• Emerging markets offer significant growth opportunities, especially where healthcare infrastructure is expanding.
• Regulatory stability and continuous clinical evidence are crucial for maintaining and expanding I-123's market footprint.

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FAQs

1. What are the primary clinical applications of Sodium Iodide I-123?
I-123 is mainly used for diagnostic imaging of the thyroid gland, including assessment of hyperthyroidism, thyroid nodules, and parathyroid function. It provides high-resolution SPECT imaging with a favorable safety profile.

2. How do recent clinical trials impact the use of I-123?
They optimize imaging protocols, enhance diagnostic accuracy through hybrid imaging and AI, and validate safety, all of which reinforce clinical confidence and market adoption.

3. What factors are driving market growth for I-123?
Increasing thyroid disorder prevalence, technological advancements like SPECT/CT, regulatory support, and expanding healthcare infrastructure drive growth.

4. What are the main challenges facing the Sodium I-123 market?
Supply chain limitations due to short half-life, high manufacturing costs, logistical hurdles, and competition from PET radiotracers pose challenges.

5. What is the future outlook for I-123 in nuclear medicine?
The outlook remains positive, with projected CAGR of 5-7%. Expanding indications, technological innovations, and emerging markets will propel growth, though logistical and regulatory constraints require strategic management.

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References

[1] ClinicalTrials.gov. "Use of SPECT/CT in Thyroid Nodule Evaluation," 2022.

[2] International Agency for Research on Cancer. "Thyroid Cancer Fact Sheet," 2020.

[3] MarketWatch. "Nuclear Medicine Radiopharmaceuticals Market Forecast," 2022.