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Last Updated: November 18, 2019

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CLINICAL TRIALS PROFILE FOR LIPIODOL

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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Lipiodol

Trial ID Title Status Sponsor Phase Start Date Summary
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 Recruiting Ecole Nationale Superieure de Chimie de Rennes Phase 1 2010-05-01 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 Recruiting Rennes University Hospital Phase 1 2010-05-01 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 Recruiting Center Eugene Marquis Phase 1 2010-05-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lipiodol

Condition Name

Condition Name for Lipiodol
Intervention Trials
Hepatocellular Carcinoma 9
Carcinoma, Hepatocellular 6
Liver Cancer 3
Lung Cancer 1
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Condition MeSH

Condition MeSH for Lipiodol
Intervention Trials
Carcinoma, Hepatocellular 22
Carcinoma 16
Liver Neoplasms 4
Liver Cirrhosis 2
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Clinical Trial Locations for Lipiodol

Trials by Country

Trials by Country for Lipiodol
Location Trials
United States 8
France 8
China 7
Taiwan 2
India 1
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Trials by US State

Trials by US State for Lipiodol
Location Trials
Pennsylvania 2
California 2
Maryland 2
Missouri 1
Minnesota 1
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Clinical Trial Progress for Lipiodol

Clinical Trial Phase

Clinical Trial Phase for Lipiodol
Clinical Trial Phase Trials
Phase 4 5
Phase 3 10
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Lipiodol
Clinical Trial Phase Trials
Recruiting 13
Not yet recruiting 8
Completed 4
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Clinical Trial Sponsors for Lipiodol

Sponsor Name

Sponsor Name for Lipiodol
Sponsor Trials
Shanghai Zhongshan Hospital 5
Sun Yat-sen University 3
Changhai Hospital 3
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Sponsor Type

Sponsor Type for Lipiodol
Sponsor Trials
Other 126
Industry 6
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