24hr Imaging Of HCC After EOVIST

• Status: Withdrawn
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

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.