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

This study is currently recruiting participants.
Verified February 2012 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Collaborator:
Bracco Diagnostics, Inc
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00539253
First received: October 2, 2007
Last updated: February 7, 2012
Last verified: February 2012
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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
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: 2007-2010 ] [ 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: 2007-2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: September 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: MultiHance
  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: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00539253     History of Changes
Other Study ID Numbers: J06108, NA_00003943
Study First Received: October 2, 2007
Last Updated: February 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
liver cancer
transarterial chemoembolization

Additional relevant MeSH terms:
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on May 16, 2013