Hepatocellular Carcinoma
Conditions
Keywords
liver cancer, transarterial chemoembolization
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.
Interventions
DRUGgadobenate dimeglumine (MultiHance)
The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
Sponsors
Bracco Diagnostics, Inc
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nodule Size | 3 months | Maximal nodule size measured in centimeters |
| Nodule Enhancement | 3 month | Percent area of nodule with enhancement |
Countries
United States
Participant flow
Recruitment details
January, 2008 to May, 2012 People with hepatocellular carcinoma who were candidates for TACE who were referred to Johns Hopkins Hospital.
Pre-assignment details
none observed
Participants by arm
| Arm | Count |
|---|---|
| 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
gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Gadobenate Dimeglumine (Multi Hance) |
|---|---|
| Age, Continuous | 60.9 years |
| Region of Enrollment United States | 45 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Nodule Enhancement
Percent area of nodule with enhancement
Time frame: 3 month
Population: Number of participants analyzed reflects the number of participants for whom data was available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multihance | Nodule Enhancement | 32.8 percent enhancement | Standard Deviation 30.7 |
Primary
Nodule Size
Maximal nodule size measured in centimeters
Time frame: 3 months
Population: The number of participants analyzed reflects the number of participants for whom data was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multihance | Nodule Size | 6.4 centimeters | Standard Deviation 4.5 |