24hr Imaging Of HCC After EOVIST



Status:Withdrawn
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2013
End Date:July 2015

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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.

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.

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.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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