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

Johns Hopkins Medicine

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Drug: gadobenate dimeglumine (MultiHance)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00539253

NA_00003943 (Other Identifier)

J06108

Details and patient eligibility

About

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).

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Gadobenate Dimeglumine (Multi Hance)

Other group

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

Treatment:

Drug: gadobenate dimeglumine (MultiHance)