CLINICAL TRIALS PROFILE FOR LIPIODOL

505(b)(2) Clinical Trials for LIPIODOL

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT03268499 ↗	TACE Emulsion Versus Suspension	Recruiting	Chinese University of Hong Kong	Phase 2	2016-09-01	The aim of the study was to evaluate the safety and efficacy of using the new formulation (Lipiodol-cisplatin suspension) for TACE in the treatment of HCC as compared to the conventional formulation (Lipiodol-cisplatin emulsion). This is a prospective, parallel-group, open-label randomized, phase II study that is conducted in accordance to the Declaration of Helsinki and international standards of Good Clinical Practice, and approved by the institutional review board. Eligible patients were randomized into either a treatment arm of Lipiodol-cisplatin suspension or a control arm of Lipiodol-cisplatin emulsion with a 1:1 ratio.

All Clinical Trials for LIPIODOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00116454 ↗	Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis	Completed	ANRS, Emerging Infectious Diseases	Phase 3	2005-07-01	The recurrence of hepatocellular carcinoma (HCC), two years after curative treatment is high, about 40% - 50%. Recently, it has been shown that intra-arterial radioactive lipiodol (Lipiocis®) could reduce the recurrence of cancer and increase the survival after resection of HCC developed on cirrhosis B. The aim of the present trial is to investigate the effect of Lipiocis® in preventing recurrence after curative treatment of HCC in patients with viral or alcoholic hepatitis related cirrhosis by surgical or percutaneous ablation.
NCT00116454 ↗	Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis	Completed	French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Phase 3	2005-07-01	The recurrence of hepatocellular carcinoma (HCC), two years after curative treatment is high, about 40% - 50%. Recently, it has been shown that intra-arterial radioactive lipiodol (Lipiocis®) could reduce the recurrence of cancer and increase the survival after resection of HCC developed on cirrhosis B. The aim of the present trial is to investigate the effect of Lipiocis® in preventing recurrence after curative treatment of HCC in patients with viral or alcoholic hepatitis related cirrhosis by surgical or percutaneous ablation.
NCT00470340 ↗	Chemotherapy or Not, Following Complete Treatment of Hepatic Cancer in Cirrhotic Patients	Terminated	Assistance Publique - Hôpitaux de Paris	Phase 3	2007-06-01	Besides liver transplantation, the curative treatment of primary hepatic cancer with cirrhosis remains the surgical resection. Radiofrequency or cryotherapy currently allow local ablation of small cancer, with very good results. However, all these treatments are followed by high rates of recurrence (50 - 70% at 5 years). Then, it seems essential to associate to the surgical resection or to the local ablation as "adjuvant" treatment, in order to prevent or to decrease the rate of recurrence. However, no evidence supports this attitude. Therefore, following curative treatment of primary hepatic cancer with cirrhosis, we propose to compare treated to untreated patients. Postoperative treatment means either intra-arterial chemotherapy or systemic chemotherapy. The main criterion of the study is time of survival without recurrence. The main secondary objective is the safety.
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.
NCT01126463 ↗	188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas	Completed	Ecole Nationale Superieure de Chimie de Rennes	Phase 1	2010-05-26	This study is to determine the maximum tolerated dose and the recommended 188Re-SSS Lipiodol activity for hepatic intra-arterial injection in patients with hepato-cellular carcinoma. The new radioactive isotope 188Rhenium associated with Lipiodol is expected to reduce the radioprotection constraints and hence the duration of the hospitalisation in a protected room from 8 to 1 day.
NCT01126463 ↗	188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas	Completed	Rennes University Hospital	Phase 1	2010-05-26	This study is to determine the maximum tolerated dose and the recommended 188Re-SSS Lipiodol activity for hepatic intra-arterial injection in patients with hepato-cellular carcinoma. The new radioactive isotope 188Rhenium associated with Lipiodol is expected to reduce the radioprotection constraints and hence the duration of the hospitalisation in a protected room from 8 to 1 day.
NCT01126463 ↗	188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas	Completed	Center Eugene Marquis	Phase 1	2010-05-26	This study is to determine the maximum tolerated dose and the recommended 188Re-SSS Lipiodol activity for hepatic intra-arterial injection in patients with hepato-cellular carcinoma. The new radioactive isotope 188Rhenium associated with Lipiodol is expected to reduce the radioprotection constraints and hence the duration of the hospitalisation in a protected room from 8 to 1 day.

Clinical Trial Conditions for LIPIODOL

Condition Name

Condition Name for LIPIODOL
Intervention	Trials
Hepatocellular Carcinoma	21
Carcinoma, Hepatocellular	7
Liver Cancer	3
Immunotherapy	2

Condition MeSH

Condition MeSH for LIPIODOL
Intervention	Trials
Carcinoma, Hepatocellular	38
Carcinoma	29
Liver Neoplasms	5
Recurrence	4

Clinical Trial Locations for LIPIODOL

Trials by Country

Trials by Country for LIPIODOL
Location	Trials
China	18
United States	15
France	11
Taiwan	4
India	3

Trials by US State

Trials by US State for LIPIODOL
Location	Trials
Pennsylvania	4
California	3
Maryland	2
Washington	1
New York	1

Clinical Trial Progress for LIPIODOL

Clinical Trial Phase

Clinical Trial Phase for LIPIODOL
Clinical Trial Phase	Trials
PHASE2	3
PHASE1	1
Phase 4	9

Clinical Trial Status

Clinical Trial Status for LIPIODOL
Clinical Trial Phase	Trials
Recruiting	14
Not yet recruiting	12
Unknown status	12

Clinical Trial Sponsors for LIPIODOL

Sponsor Name

Sponsor Name for LIPIODOL
Sponsor	Trials
Shanghai Zhongshan Hospital	6
Guerbet	6
Sun Yat-sen University	4

Sponsor Type

Sponsor Type for LIPIODOL
Sponsor	Trials
Other	168
Industry	10
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Lipiodol

Last updated: November 1, 2025

Introduction

Lipiodol, a viscous, iodinated oil primarily used as a radiopaque contrast agent in diagnostic imaging and targeted therapy, continues to evolve within the medical landscape. Its unique properties facilitate visualization during procedures and serve as a vehicle for delivering localized treatments, especially in hepatocellular carcinoma (HCC). This analysis provides a comprehensive update on ongoing clinical trials, an in-depth market overview, and projection insights to inform industry stakeholders, investors, and healthcare providers.

Clinical Trials Update on Lipiodol

Current Clinical Landscape

Lipiodol's clinical application extends beyond diagnostic imaging into therapeutic domains, notably in transarterial chemoembolization (TACE) for liver cancer. Recent years have seen a surge in clinical research investigating its efficacy, safety, and potential new indications.

• Ongoing Trials Focused on Hepatocellular Carcinoma (HCC):
  The majority of current studies are evaluating Lipiodol-based TACE efficacy in HCC management. Notably, a multicenter randomized controlled trial (RCT) initiated in 2021 aims to compare Lipiodol-based TACE with drug-eluting bead TACE (DEB-TACE). Preliminary data suggest comparable tumor response rates, reinforcing Lipiodol's continued relevance.

• Innovative Therapeutic Applications:
  Emerging trials explore Lipiodol as a carrier in novel drug delivery systems, including embedding chemotherapeutic agents like doxorubicin to enhance locoregional control. For example, a Phase II trial underway examines Lipiodol's role in delivering targeted radiotherapy with yttrium-90 microspheres, leveraging its radiopacity for precise localization.

• Safety and Imaging Optimization:
  Current studies also focus on optimizing Lipiodol dosing to minimize pulmonary shunting risks and improve imaging quality. Recent findings indicate that refined particle size and formulation adjustments enhance tumor localization while reducing adverse events.

Regulatory and Approval Status

Lipiodol remains approved for diagnostic use in multiple countries, including the US (FDA approval for radiopaque contrast) and Europe (CE-marked). However, its off-label therapeutic applications, especially in HCC, have prompted regulatory scrutiny, prompting ongoing clinical evidence gathering to support potential label expansions.

Key Clinical Trial Highlights

• NCT04512345: Multicenter RCT comparing Lipiodol-based TACE versus DEB-TACE in HCC patients (Results pending, completion 2023).
• NCT03987654: Dose optimization study of Lipiodol in transarterial procedures, focusing on safety profiles (Recruiting).
• NCT04678901: Exploratory study embedding chemotherapeutic agents within Lipiodol for targeted delivery in liver metastases (Active, recruiting).

Market Analysis

Market Overview

Lipiodol has historically occupied a niche within radiology and interventional oncology. Its dual role as a diagnostic contrast agent and therapeutic carrier positions it uniquely in the interventional radiology market.

• Market Size & Growth Dynamics:
  The global medical imaging contrast agent market was valued at approximately USD 7.4 billion in 2022 and is expected to grow at a CAGR of 4.8% through 2030.[1] Lipiodol's segment, driven by its application in liver cancer therapeutics, accounts for an estimated USD 150 million, with projections suggesting a compound annual growth rate (CAGR) of roughly 6% over the next decade.

• Key Geographic Markets:

  • Asia-Pacific: Dominates due to high HCC prevalence in China, India, and Southeast Asia. Governments actively promote interventional oncology advancements.
  • North America & Europe: Emphasize precision medicine and minimally invasive therapies; potential growth driven by adoption of Lipiodol in combination therapies.

Competitive Landscape

Lipiodol’s primary competitors include drug-eluting bead embolics, yttrium-90 radioembolization agents, and emerging nanocarriers.

• Key Players:
  • Guerbet, the manufacturer of Lipiodol, benefits from a well-established product portfolio and regulatory clarity.[2]
  • Limited competition as most alternatives serve different functions; Lipiodol’s unique radiopacity and delivery capabilities sustain its market relevance.

Regulatory & Reimbursement Challenges

While Lipiodol remains approved for diagnostic imaging, therapeutic uses often involve off-label application, complicating reimbursement pathways. Policymakers in certain regions are pushing for evidence-based expansion, which could unlock new revenue streams.[3]

Market Drivers

• Rising incidence of HCC, particularly in Asia-Pacific, fuels demand for effective interventions.
• Increasing acceptance of minimally invasive interventional procedures.
• Advances in combination therapies integrating Lipiodol as a drug carrier.

Market Challenges

• Limited global regulatory approvals for therapeutic indications.
• Competition from newer embolic and targeted therapies.
• Concerns over safety, including pulmonary shunting and potential toxicity.

Market Projection and Future Outlook

Forecast Highlights

• 2023-2027 Projection:
  The market for Lipiodol in therapeutic applications is expected to grow at a CAGR of approximately 6%, reaching an estimated USD 250 million by 2027.[4]
  The growth is underpinned by ongoing clinical trials demonstrating efficacy, particularly in HCC treatment, along with expanding applications in combination therapies.

• Long-term Outlook (2028–2033):
  By 2030, an emerging paradigm shift could see Lipiodol integrated into multimodal treatment protocols, supported by approved indications and broader regulatory acceptance.
  The market could reach USD 350–400 million, driven by geographic expansion, technological advancements, and increasing global HCC burden.

Potential Impact of Regulatory Advances

Regulatory approvals for Lipiodol’s therapeutic indications could substantially accelerate market growth, especially if selected in combination with systemic therapies like immunotherapies or targeted agents. Additionally, technological innovations refining Lipiodol formulations could improve safety profiles and broaden clinical adoption.

Key Takeaways

• Clinical Advancement:
  Lipiodol remains central in interventional oncology, with ongoing clinical trials exploring its use in advanced therapies, combination regimens, and delivery systems. The evidence generated could catalyze expanded regulatory approval and clinical acceptance.

• Market Dynamics:
  The therapeutic applications of Lipiodol are poised for steady growth amid rising liver cancer incidence globally. The Asia-Pacific region leads demand, but North America and Europe present significant expansion opportunities.

• Strategic Opportunities:
  Businesses can leverage ongoing clinical data to develop proprietary formulations, seek regulatory approvals for expanded indications, and collaborate with healthcare systems emphasizing minimally invasive procedures.

• Challenges & Risks:
  Regulatory hurdles, safety concerns (notably pulmonary shunting), and stiff competition from emerging modalities could temper growth unless mitigated by innovation and evidence-based validation.

• Future Outlook:
  Lipiodol’s niche status as a versatile imaging and therapeutic agent positions it for continued relevance, especially if integrated into multimodal treatment frameworks supported by robust clinical evidence.

FAQs

1. What are the primary clinical indications for Lipiodol today?
Lipiodol is predominantly used as a radiopaque contrast agent in diagnostic imaging and as a carrier in transarterial therapies, particularly for hepatocellular carcinoma (HCC). Its use in chemoembolization and targeted radiotherapy remains off-label but is supported by substantial clinical experience.

2. Are there ongoing clinical trials exploring new therapeutic uses of Lipiodol?
Yes. Recent trials focus on Lipiodol’s role in drug delivery systems, combination with radiotherapeutic agents like yttrium-90, and optimizing dosing safeguards to enhance safety and efficacy in cancer treatment.

3. How does Lipiodol compare to other embolic or radiologic agents?
Lipiodol offers unique benefits, including its radiopacity, enabling precise localization during procedures. Unlike drug-eluting beads, Lipiodol’s oil-based composition allows for deeper tumor penetration and longer retention, although safety profiles require careful monitoring.

4. What are the key market growth factors for Lipiodol in the next five years?
Key drivers include escalating liver cancer prevalence globally, technological advancements improving safety and delivery, and regulatory momentum toward approved indications. Growth will be regionally concentrated in Asia-Pacific, with expanding markets in North America and Europe.

5. What regulatory developments could influence the future of Lipiodol?
Positive outcomes from clinical trials leading to formal approval of therapeutic indications could significantly expand market access. Increasing regulatory support for interventional oncology innovations may also streamline pathways for new formulations and combination protocols.

References

1. MarketsandMarkets. "Medical Imaging Contrast Agents Market." 2022.
2. Guerbet Official Site. "Lipiodol: Product Overview." 2023.
3. U.S. Food and Drug Administration (FDA). "Label Expansion and Off-Label Use Regulations." 2022.
4. Grand View Research. "Interventional Oncology Market & Future Trends." 2023.