Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer
The purpose of this study is to determine the whether Lipiodol can be used as an imaging biomarker, predicting tumor response to therapy in patients with primary and metastatic liver cancer. Lipiodol-based transarterial chemoembolization (TACE) has been an accepted standard of care procedure for unresectable liver lesions for several decades. 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). Response to therapy will be evaluated every 1, 3 and 6 months by clinic visits, MRI/ CT scans and blood tests (to include assessment of liver function and tumor markers). After the 6th month, patients will be followed every 2-3 months for a period of up to 4 years.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer|
- Measuring Lipiodol deposition in tumor [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]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.
- Determining the time period of survival [ Time Frame: Baseline to 4 years ] [ Designated as safety issue: No ]We will determine the amount of time of survival for subjects after treatment.
|Study Start Date:||April 2013|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01877187
|Contact: Diane Reyes, RNemail@example.com|
|United States, Maryland|
|The Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator: Jeff Geschwind, MD|
|Sub-Investigator: Ihab Kamel, MD/ PhD|
|Sub-Investigator: Timothy Pawlik, MD/ PhD|
|Sub-Investigator: Michael Torbenson, MD|
|Sub-Investigator: Richard Wahl, MD|
|Sub-Investigator: Diane Reyes, RN|