Clinical trial · Interventional
Gadolinium Contrast-enhanced Abbreviated MRI (AMRI) vs. Standard Ultrasound for Hepatocellular Carcinoma (HCC) Surveillance in Patients With Cirrhosis
Abbreviated MRI (AMRI) vs. Ultrasound for HCC Surveillance in Cirrhosis
NCT04288323CI-TRIAL-00103098completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study compares gadolinium contrast-enhanced Abbreviated MRI (AMRI) to standard ultrasound for Hepatocellular Carcinoma (HCC) screening and surveillance in subjects with liver cirrhosis.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Liver Carcinoma | Liver Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cirrhoses | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- This is a single arm study in which all participants have one ultrasound and one abbreviated MR exam
- interventionNames
- Drug: Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid
Primary outcomes (2)
- measure
- Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection
- timeFrame
- up to one year
- description
- 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
- measure
- Reader reliability of screening modalities
- timeFrame
- up to 12 months from completion of imaging
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.