150 Participants Needed

AMRI vs. Ultrasound for Liver Cancer Surveillance

AS
YC
Overseen ByYesenia Covarrubias
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that using Gadoxetate Disodium in MRI scans helps detect liver cancer at an earlier stage compared to ultrasound alone, leading to better survival rates and slower disease progression in patients with liver cirrhosis.12345

Is gadoxetate disodium safe for use in humans?

Gadoxetate disodium, used for liver MRI, is generally safe and well-tolerated in humans, with only 1.7% of 8194 patients experiencing related adverse events like shortness of breath and nausea. No deaths were reported in the studies.678910

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

CB

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

Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents
Subject is able and willing to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, lab collection if needed, research AMRI exam, research US exam) and the three optional surveys (if subject opts in for that) within specified time windows, and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images.
Adults of any gender and ethnic background with liver cirrhosis, no matter what caused it.

Exclusion Criteria

VA patient
Does not meet UC San Diego Intravenous Contrast Media Guidelines for administration of Eovist*
History of any liver cancer
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo one ultrasound and one abbreviated MR exam for HCC detection

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

up to 12 months

Treatment Details

Interventions

  • Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid
Trial Overview The study is testing if an Abbreviated MRI (AMRI) using Gadolinium contrast is better than standard ultrasound in screening for Hepatocellular Carcinoma (HCC) in people with liver cirrhosis. Participants will undergo both AMRI and ultrasound exams.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
This is a single arm study in which all participants have one ultrasound and one abbreviated MR exam

Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid is already approved in European Union, United States, Japan for the following indications:

🇪🇺
Approved in European Union as Primovist for:
  • Hepatocellular carcinoma (HCC) diagnosis
  • Liver lesion detection
🇺🇸
Approved in United States as Eovist for:
  • Hepatocellular carcinoma (HCC) diagnosis
  • Liver lesion detection
🇯🇵
Approved in Japan as Primovist for:
  • 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

Trials
1,215
Recruited
1,593,000+

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Industry Sponsor

Trials
28
Recruited
126,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials
933
Recruited
579,000+

Findings from Research

In a study of 95 cirrhotic patients with hepatocellular carcinoma, gadoxetic acid (Gd-EOB-DTPA) showed lower contrast-to-noise ratios (CNR) during the arterial phase compared to gadobenate dimeglumine, although this difference was not statistically significant.
Gd-EOB-DTPA demonstrated higher CNR during the portal venous and equilibrium phases, suggesting it may provide better imaging quality in these later phases, but overall differences in enhancement were not statistically significant.
Comparison of Dynamic Phase Enhancement of Hepatocellular Carcinoma Using Gadoxetate Disodium vs Gadobenate Dimeglumine.Tirkes, T., Mehta, P., Aisen, AM., et al.[2022]
In a study of 382 high-risk patients for hepatocellular carcinoma (HCC), gadoxetic acid-enhanced MRI (AMRI) methods demonstrated significantly higher sensitivity for detecting early-stage HCC compared to ultrasound-only surveillance, with sensitivities of 90.7% for combined MRI and 86.0% for AMRI-only versus only 27.9% for ultrasound.
The sequential approach of complete gadoxetic acid-enhanced MRI followed by AMRI showed the highest accuracy at 96.9%, outperforming both AMRI-only and ultrasound-only methods, indicating that MRI-based surveillance is more effective for early detection of HCC in high-risk patients.
Abbreviated magnetic resonance imaging vs ultrasound for surveillance of hepatocellular carcinoma in high-risk patients.Park, HJ., Kim, SY., Singal, AG., et al.[2022]
In a study of 421 patients with cirrhosis, those who underwent surveillance with Gd-EOB-DTPA-enhanced MRI in addition to ultrasonography (USG) had a significantly higher rate of early-stage hepatocellular carcinoma (HCC) detection (95.2%) compared to those who only had USG (83.7%).
Patients in the Gd-EOB-DTPA-enhanced MRI group also experienced significantly better clinical outcomes, including longer overall survival and time to progression, indicating that this imaging technique can enhance HCC surveillance in cirrhosis patients.
Adding MRI as a Surveillance Test for Hepatocellular Carcinoma in Patients with Liver Cirrhosis Can Improve Prognosis.Yu, SJ., Yoo, JJ., Lee, DH., et al.[2023]

References

Comparison of Dynamic Phase Enhancement of Hepatocellular Carcinoma Using Gadoxetate Disodium vs Gadobenate Dimeglumine. [2022]
Abbreviated magnetic resonance imaging vs ultrasound for surveillance of hepatocellular carcinoma in high-risk patients. [2022]
Adding MRI as a Surveillance Test for Hepatocellular Carcinoma in Patients with Liver Cirrhosis Can Improve Prognosis. [2023]
Gadoxetate Acid-Enhanced MR Imaging for HCC: A Review for Clinicians. [2021]
Clinical Impact of Gadoxetic Acid-Enhanced Magnetic Resonance Imaging on Living Donor Liver Transplant. [2022]
Improved characterization of focal liver lesions with liver-specific gadoxetic acid disodium-enhanced magnetic resonance imaging: a multicenter phase 3 clinical trial. [2021]
Phase II clinical evaluation of Gd-EOB-DTPA: dose, safety aspects, and pulse sequence. [2022]
Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients. [2018]
Preclinical safety evaluation of Gd-EOB-DTPA (Primovist). [2019]
Gd-EOB-DTPA-enhanced magnetic resonance imaging for focal liver lesions in Chinese patients: a multicenter, open-label, phase III study. [2022]
Abbreviated MRI for HCC surveillance: is it ready for clinical use? [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Alternative approach of hepatocellular carcinoma surveillance: abbreviated MRI. [2021]
Gadoxetate-enhanced abbreviated MRI is highly accurate for hepatocellular carcinoma screening. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Abbreviated Liver Magnetic Resonance Imaging Protocols and Applications. [2022]
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