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

NCT ID: NCT00539253

Last Updated: 2017-09-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

gadobenate dimeglumine (MultiHance)

Intervention Type DRUG

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

Interventions

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gadobenate dimeglumine (MultiHance)

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

Intervention Type DRUG

Other Intervention Names

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MultiHance

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ihab Kamel

Role: PRINCIPAL_INVESTIGATOR

The Johns Hopkins University

Locations

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The Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00003943

Identifier Type: OTHER

Identifier Source: secondary_id

J06108

Identifier Type: -

Identifier Source: org_study_id