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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04288323
Other study ID # 171769
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date April 27, 2018
Est. completion date July 30, 2024

Study information

Verified date May 2024
Source University of California, San Diego
Contact Alexandra Schlein
Phone (858) 246- 2199
Email a1schlein@health.ucsd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study compares gadolinium contrast-enhanced Abbreviated MRI (AMRI) to standard ultrasound for Hepatocellular Carcinoma (HCC) screening and surveillance in subjects with liver cirrhosis.


Description:

Ultrasound (US) is currently used for HCC surveillance. However, US has certain limitations, so physicians use contrast CT or MRI. However, these are expensive and time-consuming procedures. We introduced an abbreviated MRI (AMRI) exam, which works well in cirrhotic and obese patients (unlike US), involves no ionizing radiation (unlike CT), and is rapid (unlike multi-phasic MRI) with total scanner times of less than ten minutes, and can be performed at about the same cost as US. This study in adult patients with cirrhosis will compare the performance of AMRI vs. US for detection of early-stage disease, and will help to define and validate a novel, rapid, accurate, and potentially cost-effective imaging protocol for HCC screening in high-risk individuals.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date July 30, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. - Adult subjects of any gender and any ethnic group with liver cirrhosis of any etiology, - 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. Exclusion Criteria: - VA patient - < 18 years of age - History of any liver cancer - MRI contraindication(s) - Subject knows that she is pregnant or states she trying to become pregnant - Positive urine pregnancy test in woman of childbearing potential - Nursing mother - Subject has known allergy to any gadolinium agent - Does not meet UC San Diego Intravenous Contrast Media Guidelines for administration of Eovist* - Clinical screening exam of the liver performed at UCSD within the prior 90 days to consent

Study Design


Intervention

Drug:
Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid
This study involves an on-label use of Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid for the ....

Locations

Country Name City State
United States University of California, San Diego La Jolla California

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Diego Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection per-patient sensitivity, specificity, positive predictive (PPV), negative predictive value (NPV) and accuracy of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening up to one year
Primary Reader reliability of screening modalities the inter- and intra-reader reliability of full AMRI vs. simulated unenhanced AMRI vs. US for HCC screening up to 12 months from completion of imaging
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