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Completed

NCT Number: NCT00539253

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

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gadobenate dimeglumine (MultiHance)

Drug

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

Other names: MultiHance

Primary outcomes

  1. Nodule Size

    Time frame: 3 months

    Maximal nodule size measured in centimeters

  2. Nodule Enhancement

    Time frame: 3 month

    Percent area of nodule with enhancement

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Bracco Diagnostics, Inc

Registry information

Official study title

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

Acronym: TACE

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Oct 4, 2007
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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