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

Hepatocellular Carcinoma Clinical Trial

— TACE  

Official title:

Assessment of Liver Cancer Response to Transcatheter Arterial Chemoembolization (TACE) Using Functional Triple-Phase MultiHance-Enhanced Magnetic Resonance Imaging (MRI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539253
• Other study ID #: J06108
• Secondary ID: NA_00003943
• Status: Completed
• Phase: N/A
• First received: October 2, 2007
• Last updated: August 28, 2017
• Start date: September 2007
• Est. completion date: December 2013

Study information

• Verified date: August 2017
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	The Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nodule Size	Maximal nodule size measured in centimeters	3 months
Primary	Nodule Enhancement	Percent area of nodule with enhancement	3 month