24hr Imaging Of HCC After EOVIST

September 22, 2015 updated by: Mukesh Harisinghani, MD, Massachusetts General Hospital

Pilot Study of Delayed, 24 Hour Imaging of Hepatocellular Carcinoma Following the Administration of the Hepatobiliary MRI Contrast Agent Gadolinium Ethoxybenzyl Dimeglumine (Eovist)

In this research study, the investigators are looking to see if MR imaging with Eovist performed 24 hours after the injection of Eovist helps improve the identification and characterization of focal liver tumors.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Before the research starts (screening): After signing the consent form, the participant will be asked to undergo some screening tests or procedures to find out if they can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that the participant does not take part in the research study. If the participants has had some of these tests or procedures recently, they may or may not have to be repeated.

  • A medical history, which includes questions about the participant's health, current medications, and any allergies.
  • An assessment of your tumor by X-ray, CT (Computerized Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (Positron Emission Tomography) scans.

If these tests show that the participant is eligible to participate in the research study, the participant will begin the study. If the participant does not meet the eligibility criteria, they will not be able to participate in this research study.

After the screening procedures confirm that the the participant is eligible to participate in the research study:

In this research study, the investigators are looking to see if MR imaging with Eovist performed 24 hours after the injection of Eovist helps improve the identification and characterization of focal liver tumors. Currently, standard Eovist-enhanced MRI examinations include imaging up to 20 minutes after the injection of Eovist. The participant will undergo a routine, standard of care Eovist MRI examination of the liver. The participant will then be asked to return on the following day so that a repeat MRI examination may be performed at approximately 24 hours after your dose of Eovist. No additional injections will be performed on the 2nd day of imaging.

Planned Follow-up:

The investigators will follow the participant through the completion of their 24 hour MRI examination.

Study Type

Interventional

Phase

  • Early Phase 1

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Massachusetts General 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must meet the following criteria on screening examination to be eligible to participate in the study:
  • Participants must have histologically or cytologically confirmed hepatocellular carcinoma OR have an imaging study that demonstrates a focal hepatic lesion with imaging features diagnostic of hepatocellular carcinoma.
  • Participants must be scheduled to undergo an Eovist-enhanced MRI of the liver as a part of their standard of care.
  • Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with MRI.
  • Because no dosing or adverse event data are currently available on the use of Eovist in participants <18 years of age, and because HCC is exceedingly rare in the pediatric population, children are excluded from this study.
  • The effects of Eovist on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
  • Participants who have had chemotherapy, radiofrequency ablation, microwave ablation, chemo-embolization, or radiotherapy within 4 weeks prior to entering the study.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Eovist.
  • Patients with glomerular filtration rates < 30 mL/min/1.73m2.
  • Patients who are unable to undergo MRI imaging.
  • Patients who are pregnant.

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
Experimental: Eovist at 24 Hour Delayed Imaging
This study will evaluate uptake of the hepatobiliary magnetic resonance imaging (MRI) contrast agent gadolinium ethoxybenzyl dimeglumine, or Eovist (Bayer Imaging, Wayne, NJ) within hepatocellular carcinomas (HCCs) at delayed, 24 hour imaging. The recommended dose of Eovist is 0.1 mL/kg, or 0.025 mmol/kg.
Drug: Eovist
Other Names:
  • gadolinium ethoxybenzyl dimeglumine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calculate the percent absolute enhancement of HCCs following Eovist administration at multiple phases
Time Frame: 24 hours
The primary objective is to calculate the percent absolute enhancement of HCCs following Eovist administration at multiple phases: arterial enhancement, portal venous enhancement, hepatobiliary enhancement, and late washout enhancement.All but the final phase of imaging are performed as part of routine clinical care and occur within the first 20 minutes. This study will investigate the behavior of HCCs with regards to Eovist enhancement at a late washout phase, which occurs after 24 hours. The primary outcome is evidence of absolute enhancement within HCC at the late washout phase.
24 hours

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Mukesh Harisinghani, MD, Massachusetts General Hospital

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

December 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

October 20, 2013

First Submitted That Met QC Criteria

October 20, 2013

First Posted (Estimate)

October 24, 2013

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-386

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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