Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI - Full Text View

Sponsors and Collaborators:	Sidney Kimmel Comprehensive Cancer Center Bracco Diagnostics, Inc
Information provided by:	Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00539253

Purpose

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).

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.

Condition	Intervention
Hepatocellular Carcinoma	Drug: gadobenate dimeglumine (MultiHance)

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Assessment of Liver Cancer Response to Transcatheter Arterial Chemoembolization Using Functional Triple-Phase MultiHance-Enhanced MRI

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Gadolinium DTPA Gadobenic acid Gadobenate Dimeglumine

U.S. FDA Resources

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:

The primary outcome measurement is agreement of tumor necrosis using triple-phase MultiHance-enhanced MRI, with the percent necrosis seen in patients following surgery or tissue biopsy. [ Time Frame: 2007-2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine if some combination of the MRI enhancement in the three phases is a better predictor of necrosis compared to enhancement in a single phase. [ Time Frame: 2007-2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Outpatients between the ages of 18 - 80 seen in the cardiovascular and interventional radiology clinic who are scheduled for TACE.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539253

Contacts

Contact: Margaret Mensa, RN	410 614 1608	mmensa2@jhmi.edu
Contact: Ihab Kamel, MD, PhD	410 955-4567	ikamel@jhmi.edu

Locations

United States, Maryland
The Johns Hopkins Hospital	Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Ihab Kamel, MD, PhD

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

Bracco Diagnostics, Inc

Investigators

Principal Investigator:

Ihab Kamel

The Johns Hopkins University

More Information

No publications provided

Responsible Party:	Johns Hopkins University ( Ihab Kamel, MD, PhD )
Study ID Numbers:	J06108, NA_00003943
Study First Received:	October 2, 2007
Last Updated:	August 5, 2009
ClinicalTrials.gov Identifier:	NCT00539253 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:

liver cancer
transarterial chemoembolization

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular

Gastrointestinal Neoplasms
Hepatocellular Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Liver Neoplasms
Liver Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Neoplasms by Histologic Type
Carcinoma, Hepatocellular
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 11, 2009