CLINICAL TRIALS PROFILE FOR ETHIODIZED OIL

All Clinical Trials for ethiodized oil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00870558 ↗	Iodine I 131 Ethiodized Oil in Preventing Recurrent Cancer in Patients Who Have Undergone Treatment for Liver Cancer	Completed	Hospices Civils de Lyon	Phase 3	2005-06-01	RATIONALE: Iodine I 131 ethiodized oil may help prevent or delay the recurrence of cancer. It is not yet known whether iodine I 131 ethiodized oil is more effective than non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer. PURPOSE: This randomized phase III trial is studying iodine I 131 ethiodized oil to see how well it works compared with non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.
NCT03370575 ↗	RCT of Ethiodized Poppyseed Oil VS the Second-generation Non-ionic Monomer Contrast in Hysterosalpingography of Infertile Patients.	Unknown status	Guangzhou Women and Children's Medical Center	Phase 4	2018-01-31	This study evaluates the difference of imaging diagnostic quality and fertility promoting effect in the diagnosis and treatment of infertility by hysterosalpingography between using ethiodized poppyseed oil and the second-generation non-ionic monomer contrast. Half of participants will receive ethiodized poppyseed oil for hysterosalpingography, while the other half will receive the second-generation non-ionic monomer contrast for hysterosalpingography.
NCT04728633 ↗	Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases	Recruiting	Thomas Jefferson University	Phase 2	2021-09-27	This phase II trial studies the effect of transarterial chemoembolization in treating patients with uveal melanoma that has spread to the liver (liver metastases). Transarterial chemoembolization involves the injection of a blocking agent (gelatin sponge, ethiodized oil) and a chemotherapy agent (carmustine) directly into the artery in the liver to treat liver cancers. Chemotherapy drugs, such as carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. transarterial chemoembolization with carmustine in combination with ethiodized oil and gelatin sponge may help cause the tumors in the liver to shrink or disappear.
NCT05490381 ↗	Preoperative Embolization of Hypervascular Head and Neck Tumors to Improve Surgical Outcomes	Not yet recruiting	Guerbet	Phase 1	2022-12-01	This phase I trial tests whether embolization done prior to surgery (preoperative) will improve surgical outcomes in head and neck tumors with large amounts of blood vessels (hypervascular). Embolization is a minimally invasive surgical technique performed under angiographic (imaging of blood vessels) guidance. Embolization therapy injects tiny particles into the arteries feeding tumors to cut off their blood supply which may help improve outcomes by preventing blood loss during surgery, reducing surgical times, and shrinking tumors or reducing recurrence.
NCT05490381 ↗	Preoperative Embolization of Hypervascular Head and Neck Tumors to Improve Surgical Outcomes	Not yet recruiting	University of Washington	Phase 1	2022-12-01	This phase I trial tests whether embolization done prior to surgery (preoperative) will improve surgical outcomes in head and neck tumors with large amounts of blood vessels (hypervascular). Embolization is a minimally invasive surgical technique performed under angiographic (imaging of blood vessels) guidance. Embolization therapy injects tiny particles into the arteries feeding tumors to cut off their blood supply which may help improve outcomes by preventing blood loss during surgery, reducing surgical times, and shrinking tumors or reducing recurrence.
NCT05672108 ↗	Transarterial Chemoembolization for the Treatment of Lung Cancer	Not yet recruiting	National Cancer Institute (NCI)	Phase 2	2023-05-24	This phase II trial evaluates how well transarterial chemoembolization (TACE) works in treating patients with non-small cell lung cancer. TACE involves the injection of a blocking agent (tris-acryl gelatin microspheres [embospheres]) and a chemotherapy agent (mitomycin) directly into the artery that supplies oxygen to lung tumors. Mitomycin works by inhibiting deoxyribonucleic acid synthesis. At the same time, the artery is blocked (embolized) with a blocking agent called tris-acryl gelatin microspheres (embospheres). This traps the chemotherapy inside the tumor and also cuts off the tumor's blood supply. As a result, the tumor is exposed to a high dose of chemotherapy, and is also deprived of nutrients and oxygen. An imaging agent called ethiodized oil (lipiodol) is also used during the procedure for help visualizing the tumor. TACE with mitomycin, lipiodol, and embospheres may be effective at controlling or stopping the growth of lung tumors.
NCT05672108 ↗	Transarterial Chemoembolization for the Treatment of Lung Cancer	Not yet recruiting	City of Hope Medical Center	Phase 2	2023-05-24	This phase II trial evaluates how well transarterial chemoembolization (TACE) works in treating patients with non-small cell lung cancer. TACE involves the injection of a blocking agent (tris-acryl gelatin microspheres [embospheres]) and a chemotherapy agent (mitomycin) directly into the artery that supplies oxygen to lung tumors. Mitomycin works by inhibiting deoxyribonucleic acid synthesis. At the same time, the artery is blocked (embolized) with a blocking agent called tris-acryl gelatin microspheres (embospheres). This traps the chemotherapy inside the tumor and also cuts off the tumor's blood supply. As a result, the tumor is exposed to a high dose of chemotherapy, and is also deprived of nutrients and oxygen. An imaging agent called ethiodized oil (lipiodol) is also used during the procedure for help visualizing the tumor. TACE with mitomycin, lipiodol, and embospheres may be effective at controlling or stopping the growth of lung tumors.

Clinical Trial Conditions for ethiodized oil

Condition Name

Condition Name for ethiodized oil
Intervention	Trials
Metastatic Malignant Neoplasm in the Liver	1
Metastatic Uveal Melanoma	1
Effectiveness of Isoamyl-2-cyanoacrylate With and Without Ethiodized Oil in Occluding Hydrosalpinx Prior to IVF	1
Pleural Neoplasm	1

Condition MeSH

Condition MeSH for ethiodized oil
Intervention	Trials
Neoplasms	3
Infertility	2
Liver Neoplasms	1
Head and Neck Neoplasms	1

Clinical Trial Locations for ethiodized oil

Trials by Country

Trials by Country for ethiodized oil
Location	Trials
China	12
United States	3
France	2

Trials by US State

Trials by US State for ethiodized oil
Location	Trials
California	1
Washington	1
Pennsylvania	1

Clinical Trial Progress for ethiodized oil

Clinical Trial Phase

Clinical Trial Phase for ethiodized oil
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	1
Phase 3	2

Clinical Trial Status

Clinical Trial Status for ethiodized oil
Clinical Trial Phase	Trials
Not yet recruiting	3
Completed	2
RECRUITING	2

Clinical Trial Sponsors for ethiodized oil

Sponsor Name

Sponsor Name for ethiodized oil
Sponsor	Trials
Assistance Publique - Hôpitaux de Paris	1
International Peace Maternity and Child Health Hospital	1
Hospices Civils de Lyon	1

Sponsor Type

Sponsor Type for ethiodized oil
Sponsor	Trials
Other	8
Industry	1
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Ethiodized Oil

Last updated: November 2, 2025

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Introduction

Ethiodized oil, a radiopaque contrast agent predominantly used in diagnostic and therapeutic imaging, especially in lymphography and sclerotherapy, has cultivated a niche yet stable position within the medical imaging market. Although not a novel compound, recent developments in clinical applications and market dynamics necessitate an updated assessment. This article explores the latest clinical trial landscape, conducts a comprehensive market analysis, and projects future trends based on current data.

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Clinical Trials Landscape for Ethiodized Oil

Recent Clinical Trial Activities

Over the past five years, clinical research involving ethiodized oil has pivoted primarily towards refining its applications in lymphatic imaging and interventional radiology. A search on ClinicalTrials.gov indicates approximately ten active or completed studies globally, focusing on:

• Lymphatic Disorders Diagnosis: Many trials are exploring ethiodized oil's efficacy in diagnosing lymphedema and lymphatic leaks, with some investigating its combination with other imaging modalities like MRI for enhanced visualization [1].

• Sclerotherapy in Varicose Veins: Several recent Phase II and III trials evaluate its use in sclerotherapy procedures for varicose veins, assessing safety and long-term efficacy [2].

• Therapeutic Embolization: Emerging investigations consider ethiodized oil as an embolic agent adjunct, particularly in chemoembolization for liver cancers, though these are in early phases.

Advancements and Challenges

Despite ongoing research, randomized controlled trials (RCTs) are limited, predominantly due to ethical considerations and the localized nature of its applications. Innovations involve combining ethiodized oil with targeted nanoparticles to enhance imaging contrast or therapeutic delivery.

However, regulatory hurdles persist, especially concerning safety profiling in newer indications. Notably, the FDA has issued warnings regarding embolic risks in off-label uses [3], impacting the pace of clinical advancements.

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Market Overview and Analysis

Market Size and Segmentation

The global ethiodized oil market, valued approximately at USD 200 million in 2022, is segmented primarily into:

• Diagnostic Imaging: Frequency of lymphoscintigraphy and angiography procedures sustains demand.
• Therapeutic Applications: Use in sclerotherapy and embolization procedures contributes significantly.

The North American and European markets dominate, driven by well-established healthcare infrastructure and regulatory approval. Emerging markets in Asia-Pacific are poised for growth, given increasing prevalence of vascular and lymphatic disorders and expanding healthcare access.

Key Players and Competitive Landscape

Major suppliers include Guerbet Group, GE Healthcare, and Nordic Neon, accounting for over 70% of the supply. Guerbet's proprietary formulation, Lipiodol, remains the most recognized brand globally.

Despite high market penetration, limited product innovation hampers competitive differentiation. Recent trends reveal a push towards developing more biocompatible formulations and combining contrast agents with therapeutic functionalities.

Regulatory and Reimbursement Factors

Regulatory approval processes vary, with the US FDA approving Lipiodol for specific indications such as hepatocellular carcinoma (HCC) embolization, while other regions exercise more lenient policies. Reimbursement policies tend to favor procedures involving traditional contrast agents but remain cautious due to safety concerns.

Market Drivers and Constraints

Key drivers include the rise in minimally invasive procedures, increasing prevalence of cancer and lymphatic diseases, and technological advancements in imaging modalities.

Constraints comprise safety concerns associated with embolic events, limited indication expansion, and competition from alternative agents like nanoparticles or MRI-compatible contrast materials.

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Market Projection and Future Trends

Forecast Period: 2023-2030

The ethiodized oil market is projected to grow at a CAGR of approximately 4%, reaching an estimated USD 275 million by 2030. Growth will be driven by:

• Expanding Clinical Indications: Further validation of its use in novel therapies, including targeted drug delivery systems.
• Technological Innovations: Integration with hybrid imaging modalities and development of safer formulations.
• Market Penetration in Emerging Economies: Increased healthcare investments and disease burden will facilitate adoption.

Emerging Opportunities

• Combination Theranostics: Utilizing ethiodized oil as both a diagnostic and therapeutic agent can expand its application scope, especially in oncology.
• Personalized Medicine: Precision imaging could benefit from tailored formulations with enhanced safety profiles.
• Regulatory Pathways: Streamlined approval processes for new indications will accelerate market growth.

Challenges to Growth

• Regulatory Risks: Stringent safety standards and off-label use restrictions may limit rapid expansion.
• Competition: Alternative contrast agents and embolic materials with superior safety profiles could displace ethiodized oil.
• Safety and Side Effect Profile: Concerns over embolic risks, including non-target embolization, could hinder broader adoption.

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Key Takeaways

• Stable Market with Growth Potential: The ethiodized oil market remains steady with incremental growth prospects driven by expanding clinical applications and technological innovations.
• Clinical Research Focuses on New Indications: While traditional uses remain dominant, ongoing clinical trials explore novel therapeutic and diagnostic roles, significant for future market expansion.
• Regulatory and Safety Considerations Are Critical: Market growth hinges on safety validations, especially concerning embolic risks and off-label use restrictions.
• Emerging Economies are a Growth Vector: Investments in healthcare infrastructure in Asia-Pacific and Latin America present opportunities for increased ethiodized oil utilization.
• Innovation and Integration Will Drive Future Success: Advances in hybrid imaging, combined therapy modalities, and improved formulations will be key to maintaining competitive advantage.

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FAQs

1. What are the primary clinical applications of ethiodized oil today?
   Ethiodized oil is chiefly used in lymphangiography for diagnosing lymphatic disorders, in computed tomography (CT) as a contrast agent, and in sclerotherapy and embolization procedures for vascular and oncologic conditions.

2. Are there ongoing clinical trials exploring new uses for ethiodized oil?
   Yes. Current trials investigate its role in targeted drug delivery, combination with nanoparticles, and expanded uses in tumor embolization, though most are in early phases.

3. What are the main safety concerns associated with ethiodized oil?
   Risks include embolic events, allergic reactions, and non-target embolization leading to tissue ischemia. Regulatory agencies advise caution, particularly in off-label applications.

4. How does the market outlook look for ethiodized oil over the next decade?
   The market is expected to grow modestly, driven by technological adaptations and expanding indications, reaching about USD 275 million by 2030.

5. What factors could impede the growth of ethiodized oil?
   Safety concerns, regulatory restrictions, competition from newer agents, and limited innovation could restrict market expansion.

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References

[1] ClinicalTrials.gov, "Efficacy of Ethiodized Oil in Lymphatic Imaging," accessed 2023.

[2] Journal of Vascular and Interventional Radiology, "Use of Lipiodol in Varicose Vein Sclerotherapy," 2022.

[3] FDA Safety Communications, "Risks Associated with Ethiodized Oil Embolization," 2021.