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Contrast Agent

AMRI vs. Ultrasound for Liver Cancer Surveillance

Phase 4

Recruiting

Led By Claude B Sirlin, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one year

Awards & highlights

Study Summary

This trial compares the use of gadolinium contrast-enhanced Abbreviated MRI (AMRI) to standard ultrasound for the screening and surveillance of subjects with liver cirrhosis who are at risk for developing hepatocellular carcinoma (HCC).

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to the gadolinium contrast agent used during the AMRI procedure. These could range from mild skin rashes to more severe reactions depending on individual sensitivity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection

Reader reliability of screening modalities

Trial Design

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,119 Previous Clinical Trials

1,521,355 Total Patients Enrolled

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering PharmaIndustry Sponsor

25 Previous Clinical Trials

122,005 Total Patients Enrolled

1 Trials studying Liver Cancer

5 Patients Enrolled for Liver Cancer

Icahn School of Medicine at Mount SinaiOTHER

858 Previous Clinical Trials

524,141 Total Patients Enrolled

2 Trials studying Liver Cancer

1,400 Patients Enrolled for Liver Cancer

Media Library

Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid (Contrast Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04288323 — Phase 4

Liver Cancer Research Study Groups: Single arm

Liver Cancer Clinical Trial 2023: Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid Highlights & Side Effects. Trial Name: NCT04288323 — Phase 4

Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid (Contrast Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04288323 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of individuals who may be enrolled in this medical experiment?

"Affirmative. Clinicaltrials.gov corroborates that this scientific experiment is still recruiting patients, with the original post dating back to April 27th 2018 and the most recent edit on April 6th 2022. 150 participants from 1 medical centre are needed for successful completion of this trial."

Answered by AI

Is it currently feasible for people to join this clinical trial?

"Affirmative, according to the records on clinicaltrials.gov this investigation is actively trying to recruit patients. The trial was initially posted in April 2018 and recently updated in April 2022 with a target of 150 participants at 1 site."

Answered by AI

Has the FDA sanctioned Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid?

"With it's Phase 4 status, our team at Power has assigned Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid a score of 3 on the safety scale. This is because the treatment is already approved for use."

Answered by AI

Are there any other studies that have utilized Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid?

"Currently, there are 10 clinical trials occurring in regards to Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid with none of them in the third phase. Birmingham, Alabama is one of 26 cities conducting studies relating to this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gadolinium Contrast-enhanced Abbreviated MRI (AMRI) vs. Standard Ultrasound for Hepatocellular Carcinoma (HCC) Surveillance in Patients With Cirrhosis

Claude Sirlin 2018. "Gadolinium Contrast-enhanced Abbreviated MRI (AMRI) vs. Standard Ultrasound for Hepatocellular Carcinoma (HCC) Surveillance in Patients With Cirrhosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04288323.

All > Hcc > Hepatocellular Carcinoma