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.

Clinical Trial Conditions for Lipiodol

Condition Name

Condition Name for Lipiodol
Intervention	Trials
Hepatocellular Carcinoma	19
Carcinoma, Hepatocellular	7
Liver Cancer	3
Lung Cancer	2

Condition MeSH

Condition MeSH for Lipiodol
Intervention	Trials
Carcinoma, Hepatocellular	35
Carcinoma	29
Liver Neoplasms	5
Neoplasms	4

Clinical Trial Locations for Lipiodol

Trials by Country

Trials by Country for Lipiodol
Location	Trials
China	17
United States	15
France	10
Taiwan	3
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
Phase 4	9
Phase 3	12
Phase 2/Phase 3	5

Clinical Trial Status

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

Clinical Trial Sponsors for Lipiodol

Sponsor Name

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

Sponsor Type

Sponsor Type for Lipiodol
Sponsor	Trials
Other	159
Industry	10
NIH	2

Lipiodol: Clinical Trials, Market Analysis, and Projections

Introduction

Lipiodol, an ethiodized oil, has been a crucial component in the treatment of liver cancers, particularly in procedures like transarterial chemoembolization (TACE). This article delves into the current state of clinical trials, market analysis, and future projections for Lipiodol.

Clinical Trials and Efficacy

Role in TACE

Lipiodol serves multiple roles in TACE, including as a carrier for chemotherapeutic drugs, an embolic agent, and a predictor for tumor response and survival. A prospective clinical trial analyzed the 3D quantitative assessment of intra-procedural Lipiodol deposition in liver tumors using cone-beam computed tomography (CBCT)[1].

Key Findings

• The study found a high degree of agreement between Lipiodol deposition on CBCT and 24-hour post-TACE multidetector computed tomography (MDCT), indicating that acquiring MDCT 24 hours after TACE might be redundant[1].
• There was a statistically significant inverse relationship between Lipiodol deposition and tumor response, with higher deposition associated with better response rates and longer median overall survival (MOS)[1].
• The optimal dosage of Lipiodol is critical; studies suggest using a dosage equivalent to 1.0 to 1.5 times the tumor diameter for best long-term prognosis, with adjustments for highly vascularized tumors[3].

Ongoing and Completed Trials

A completed clinical trial (EudraCT Number: 2020-002206-10) in France evaluated the use of Lipiodol Ultra Fluide in TACE procedures. This trial, which was not randomized or controlled, focused on the safety and efficacy of Lipiodol in adult and elderly patients[4].

Market Analysis

Current Market Size and Growth

The global Lipiodol market has been expanding steadily. As of 2018, the market size was valued at a significant amount, and it is projected to grow at a compound annual growth rate (CAGR) from 2019 to 2025[2].

Market Segmentation

The market is segmented by application, with TACE being a primary use. The consumption of Lipiodol varies by region, with global and Chinese markets showing different growth patterns. The market analysis includes detailed forecasts for capacity, production, and production value up to 2029[2].

Industry Chain and Economic Impact

The Lipiodol industry is influenced by upstream raw materials, downstream industries, and macroeconomic factors. The industry chain structure, production costs, and profit estimations are crucial for understanding the market dynamics. Global and Chinese economic environments play significant roles in shaping the market trends[2].

Market Projections

Forecast to 2029

The global and Chinese Lipiodol markets are expected to continue growing, with projections indicating increased capacity, production, and production value. The market share of key manufacturers and the supply and consumption patterns are expected to evolve, influenced by economic and technological factors[2].

Market Opportunities and Challenges

The Lipiodol market faces both opportunities and challenges. Opportunities include advancements in interventional treatment techniques and the increasing incidence of liver cancers, which drive the demand for effective treatments like TACE. Challenges include the need for precise quantitative dosing and the potential for liver damage if not managed correctly[3].

Economic Impact

Global and Chinese Macroeconomic Environment

The global and Chinese macroeconomic environments significantly impact the Lipiodol market. Factors such as economic growth, healthcare policies, and technological advancements influence the market's expansion and stability[2].

Industry Development

The industry is expected to benefit from advancements in precision intervention and the development of new treatment strategies. However, it must also navigate challenges such as regulatory changes and the need for continuous innovation to maintain market share[2].

Conclusion

Lipiodol remains a vital component in the treatment of liver cancers, particularly through TACE procedures. Clinical trials have reinforced its role as a predictive biomarker for tumor response and survival. The market analysis indicates a growing demand driven by increasing incidence of liver cancers and advancements in interventional treatments. As the market continues to expand, it is crucial for manufacturers and healthcare providers to stay abreast of the latest clinical findings and market trends.

Key Takeaways

• Lipiodol is a critical component in TACE procedures for liver cancers.
• Clinical trials have shown that 3D quantitative assessment of Lipiodol deposition is a predictive biomarker for tumor response and survival.
• The global Lipiodol market is projected to grow, driven by increasing demand and advancements in treatment techniques.
• Market segmentation and economic factors play significant roles in shaping the industry's future.
• Precise dosing and minimizing liver damage are key challenges in the use of Lipiodol.

FAQs

What is Lipiodol used for in medical procedures?

Lipiodol is used as a carrier for chemotherapeutic drugs, an embolic agent, and a predictor for tumor response and survival in transarterial chemoembolization (TACE) procedures for liver cancers.

How is the efficacy of Lipiodol evaluated in clinical trials?

The efficacy of Lipiodol is evaluated through 3D quantitative assessment of its deposition in liver tumors using imaging techniques like CBCT and MDCT. Tumor response and survival rates are key metrics.

What are the market projections for Lipiodol up to 2029?

The global and Chinese Lipiodol markets are expected to grow, with increased capacity, production, and production value projected up to 2029.

What are the key challenges in the use of Lipiodol?

Key challenges include the need for precise quantitative dosing to maximize tumor embolization while minimizing liver damage.

How does the macroeconomic environment impact the Lipiodol market?

The global and Chinese macroeconomic environments influence the Lipiodol market through factors such as economic growth, healthcare policies, and technological advancements.

Sources

1. Lipiodol as an intra-procedural imaging biomarker for liver tumor ... - PubMed
2. Lipiodol Market Size, Share, Trend and Forecast to 2025 - Prof Research
3. Research Progress on the Prediction of TACE Efficacy by Lipiodol ... - SCIRP
4. EU Clinical Trials Register - Clinical Trials Register
5. Evaluation of Predictive Factors for Transarterial Bleomycin–Lipiodol ... - MDPI