drugset / Trial / NCT01877187

Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer

NCT01877187

Phase 2 Completed 39 enrolled Yale University Guerbet · collab
NaSingle-groupOpen-labelOther

Summary

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/PET scans and blood tests (to include assessment of liver function and tumor markers).

Timeline

Start
2013-04
Primary completion
2020-02
Completion
2020-02

Drugs

EvaluationDrugModalityDoseRoute
Subject lipiodol Unknown 10 ml Other

Indications