Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01877187|
Recruitment Status : Active, not recruiting
First Posted : June 13, 2013
Last Update Posted : February 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: Lipiodol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer|
|Actual Study Start Date :||April 2013|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||March 2019|
Lipiodol, 10cc per TACE.
Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
Other Name: Ethiodol
- Tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 6 months ]Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with RECIST response separately using contrast CT, MRI and PET imaging.
- 6-month survival rate of patients with HCC and liver metastases treated with conventional TACE [ Time Frame: 6 months ]Measure the association between baseline Lipiodol deposition and the 6-month survival rate by estimating median survival for each stratum, and by testing for homogeneity using a logrank test if hazards are proportional.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877187
|United States, Connecticut|
|Smilow Cancer Center|
|New Haven, Connecticut, United States, 06510|
|United States, Maryland|
|The Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Jean-Francois (Jeff) Geschwind, MD||Yale University|