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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: gadobenate dimeglumine (MultiHance)

• Registration Number: NCT00539253
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-02
• Study First Submitted QC: 2007-10-03
• Study First Posted: 2007-10-04
• Primary Completion: 2013-03
• Study Completion: 2013-12
• Results First Submitted: 2016-10-12
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-28
• Last Update Submitted: 2017-08-28
• Results First Posted: 2017-09-26
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gadobenate Dimeglumine (Multi Hance)	gadobenate dimeglumine (MultiHance)	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

Primary Outcome Measures

Name	Time	Method
Nodule Size	3 months	Maximal nodule size measured in centimeters
Nodule Enhancement	3 month	Percent area of nodule with enhancement

Trial Locations

Locations (1)

The Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States