AMRI vs. Ultrasound for Liver Cancer Surveillance
Trial Summary
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the drug Gadoxetate Disodium for liver cancer surveillance?
Is gadoxetate disodium safe for use in humans?
How is the treatment Gadoxetate Disodium different from other liver cancer surveillance methods?
Gadoxetate Disodium is used in an abbreviated MRI (AMRI) approach, which is a high-sensitivity alternative to ultrasound for liver cancer surveillance, especially in patients where ultrasound may not work well, like those with cirrhosis or obesity. This treatment involves a special contrast agent that enhances MRI images, making it easier to detect early-stage liver cancer.211121314
What is the purpose of this trial?
This study compares gadolinium contrast-enhanced Abbreviated MRI (AMRI) to standard ultrasound for Hepatocellular Carcinoma (HCC) screening and surveillance in subjects with liver cirrhosis.
Research Team
Claude B Sirlin, MD
Principal Investigator
University of California, San Diego
Eligibility Criteria
This trial is for adults of any gender and ethnicity with liver cirrhosis who can sign consent, complete research procedures, and allow access to their clinical data. It's not for those under 18, pregnant or nursing women, patients with a history of liver cancer or known allergies to gadolinium agents, or anyone contraindicated for MRI.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants undergo one ultrasound and one abbreviated MR exam for HCC detection
Follow-up
Participants are monitored for safety and effectiveness after imaging
Treatment Details
Interventions
- Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid
Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid is already approved in European Union, United States, Japan for the following indications:
- Hepatocellular carcinoma (HCC) diagnosis
- Liver lesion detection
- Hepatocellular carcinoma (HCC) diagnosis
- Liver lesion detection
- Hepatocellular carcinoma (HCC) diagnosis
- Liver lesion detection
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Industry Sponsor
Icahn School of Medicine at Mount Sinai
Collaborator