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

August 28, 2017 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • MultiHance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nodule Size
Time Frame: 3 months
Maximal nodule size measured in centimeters
3 months
Nodule Enhancement
Time Frame: 3 month
Percent area of nodule with enhancement
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Bracco Diagnostics, Inc

Investigators

  • Principal Investigator: Ihab Kamel, The Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 2, 2007

First Submitted That Met QC Criteria

October 3, 2007

First Posted (Estimate)

October 4, 2007

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J06108
  • NA_00003943 (Other Identifier: Johns Hopkins I.R.B.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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