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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00539253
First Posted: October 4, 2007
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bracco Diagnostics, Inc
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
  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).

Condition Intervention
Hepatocellular Carcinoma Drug: gadobenate dimeglumine (MultiHance)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Liver Cancer Response to Transcatheter Arterial Chemoembolization (TACE) Using Functional Triple-Phase MultiHance-Enhanced Magnetic Resonance Imaging (MRI)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Nodule Size [ Time Frame: 3 months ]
    Maximal nodule size measured in centimeters

  • Nodule Enhancement [ Time Frame: 3 month ]
    Percent area of nodule with enhancement


Enrollment: 45
Study Start Date: September 2007
Study Completion Date: December 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gadobenate Dimeglumine (Multi Hance)
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
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539253


Locations
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Bracco Diagnostics, Inc
Investigators
Principal Investigator: Ihab Kamel The Johns Hopkins University
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00539253     History of Changes
Other Study ID Numbers: J06108
NA_00003943 ( Other Identifier: Johns Hopkins I.R.B. )
First Submitted: October 2, 2007
First Posted: October 4, 2007
Results First Submitted: October 12, 2016
Results First Posted: September 26, 2017
Last Update Posted: September 26, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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