Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI
This research is being done to find out if using the contrast agent MultiHance can be used to show how a liver tumor responds to the chemotherapy given during Transcatheter Arterial Chemoembolization (TACE).
MultiHance is approved by the Food and Drug Administration (FDA) for use as a contrast material for Magnetic Resonance Imaging (MRI) scans of the central nervous system. It is believed that using MultiHance may be able to help doctors tell normal liver cells apart from active tumor and from tumor affected by the chemotherapy. In this way, MultiHance may improve the way patients with hepatocellular carcinoma are managed clinically.
We hypothesize that the Multi-Hance contrast material will provide better image definition of treated liver tumor(s) on MRI imaging in comparison to other commercially available contrast agents.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Assessment of Liver Cancer Response to Transcatheter Arterial Chemoembolization Using Functional Triple-Phase MultiHance-Enhanced MRI|
- The primary outcome measurement is agreement of tumor necrosis using triple-phase MultiHance-enhanced MRI, with the percent necrosis seen in patients following surgery or tissue biopsy. [ Time Frame: 2007-2010 ] [ Designated as safety issue: No ]
- To determine if some combination of the MRI enhancement in the three phases is a better predictor of necrosis compared to enhancement in a single phase. [ Time Frame: 2007-2010 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||December 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
No Intervention: No intervention
If patient did not participate in this study (by signing consent), they could recieve any other contrast used routinely at this facility including the contrast used in this study
Drug: gadobenate dimeglumine (MultiHance)
The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
Other Name: MultiHance
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539253
|United States, Maryland|
|The Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Ihab Kamel||The Johns Hopkins University|