Back to resultsAssessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI. (TACE)
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
gadobenate dimeglumine (MultiHance)
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring liver cancer, transarterial chemoembolization
Eligibility Criteria
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
Sites / Locations
- The Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Gadobenate Dimeglumine (Multi Hance)
Arm Description
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
Outcomes
Primary Outcome Measures
Nodule Size
Maximal nodule size measured in centimeters
Nodule Enhancement
Percent area of nodule with enhancement
Secondary Outcome Measures
Full Information
NCT ID
NCT00539253
First Posted
October 2, 2007
Last Updated
August 28, 2017
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Bracco Diagnostics, Inc
1. Study Identification
Unique Protocol Identification Number
NCT00539253
Brief Title
Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI.
Acronym
TACE
Official Title
Assessment of Liver Cancer Response to Transcatheter Arterial Chemoembolization (TACE) Using Functional Triple-Phase MultiHance-Enhanced Magnetic Resonance Imaging (MRI)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
Bracco Diagnostics, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
liver cancer, transarterial chemoembolization
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gadobenate Dimeglumine (Multi Hance)
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
gadobenate dimeglumine (MultiHance)
Other Intervention Name(s)
MultiHance
Intervention Description
The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
Primary Outcome Measure Information:
Title
Nodule Size
Description
Maximal nodule size measured in centimeters
Time Frame
3 months
Title
Nodule Enhancement
Description
Percent area of nodule with enhancement
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ihab Kamel
Organizational Affiliation
The Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI.
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