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Contrast Agent

Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid for Liver Cancer

University of California, San Diego, La Jolla, CA
Targeting 3 different conditionsGadolinium ethoxybenzyl diethylenetriamine pentaacetic acidPhase 4RecruitingLed by Claude B Sirlin, MDResearch Sponsored by University of California, San Diego

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).

Eligible Conditions
  • Liver Cancer
  • Liver Cirrhosis

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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Adults of any gender and ethnic background with liver cirrhosis, no matter what caused it.

Timeline

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

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

Find a site

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,065 Previous Clinical Trials
1,837,488 Total Patients Enrolled
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering PharmaIndustry Sponsor
25 Previous Clinical Trials
122,191 Total Patients Enrolled
1 Trials studying Liver Cancer
5 Patients Enrolled for Liver Cancer
Icahn School of Medicine at Mount SinaiOTHER
816 Previous Clinical Trials
510,758 Total Patients Enrolled
2 Trials studying Liver Cancer
1,905 Patients Enrolled for Liver Cancer
Claude B Sirlin, MDPrincipal Investigator
University of California, San Diego
2 Previous Clinical Trials
80 Total Patients Enrolled

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.
~7 spots leftby Dec 2023
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