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Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI. (TACE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00539253
First Posted: October 4, 2007
Last Update Posted: September 26, 2017
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.
Collaborator:
Bracco Diagnostics, Inc
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
October 2, 2007
October 4, 2007
October 12, 2016
September 26, 2017
September 26, 2017
September 2007
March 2013   (Final data collection date for primary outcome measure)
  • Nodule Size [ Time Frame: 3 months ]
    Maximal nodule size measured in centimeters
  • Nodule Enhancement [ Time Frame: 3 month ]
    Percent area of nodule with enhancement
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.
Complete list of historical versions of study NCT00539253 on ClinicalTrials.gov Archive Site
Not Provided
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.
Not Provided
Not Provided
 
Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI.
Assessment of Liver Cancer Response to Transcatheter Arterial Chemoembolization (TACE) Using Functional Triple-Phase MultiHance-Enhanced Magnetic Resonance Imaging (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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Hepatocellular Carcinoma
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
Gadobenate Dimeglumine (Multi Hance)
If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study
Intervention: Drug: gadobenate dimeglumine (MultiHance)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
December 2013
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Outpatients between the ages of 18 - 80 seen in the cardiovascular and interventional radiology clinic who are scheduled for TACE.
  • International Normalized Ratio (INR) <1.4
  • Platelet count > 80,000

Exclusion Criteria:

  • Contraindications to TACE procedure
  • Unable to have an MRI Scan
  • Allergy or hypersensitivity reactions to gadolinium or any other ingredients, including benzyl alcohol
  • Patients with sickle cell anemia , hemoglobinopathies and other hemolytic anemias
  • Known clinical hypersensitivity or a history of asthma or allergic respiratory disorders
  • Patients with advanced renal failure (those currently requiring dialysis or with a Glomerular Filtration Rate<15cc/min)
  • Pregnancy
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00539253
J06108
NA_00003943 ( Other Identifier: Johns Hopkins I.R.B. )
No
Not Provided
Plan to Share IPD: No
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Bracco Diagnostics, Inc
Principal Investigator: Ihab Kamel The Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP