CEUS vs. AMRI for HCC Detection in Patients With Indeterminate Liver Nodules

Hepatocellular Carcinoma Clinical Trial

Official title:

Contrast Ultrasound vs. Abbreviated MRI for Detection of HCC in Patients With Indeterminate Liver Nodules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184152
• Other study ID #: 1U01CA283935
• Status: Recruiting
• Start date: November 28, 2023
• Est. completion date: November 2028

Study information

• Verified date: December 2023
• Source: University of Texas Southwestern Medical Center
• Contact: Lisa Quirk, MS/MPH
• Phone: 214-645-6179
• Email: lisa.quirk[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study will be conducted at the following locations:

1. UT Southwestern Medical Center

2. Parkland Health and Hospital System

3. University of Michigan

Investigators will prospectively compare the performance of dynamic contrast enhanced abbreviated MRI (AMRI) and contrast-enhanced ultrasound for early-stage HCC detection in patients with indeterminate liver nodules.

Description:

Investigators will prospectively perform both abbreviated MRI and contrast-enhanced ultrasound in enrolled patients every 3-6 months. Contrast-enhanced ultrasound and abbreviated MRI will preferably be done the same day, although will be permitted to be completed within 30 days of each other. Abbreviated MRI and contrast-enhanced ultrasound will be performed every 3-6 months until HCC development, regression to LR-1 or LR-2 (i.e., definitely or likely benign, respectively), or end of follow-up at 24 months post-enrollment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 2028
• Est. primary completion date: November 2028
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Child A or B cirrhosis from any etiology with at least one ILN on 4-phase CT, contrast- enhanced MRI, or contrast enhanced US but without HCC at baseline.

• Adults 18 years old and above

Exclusion Criteria:

• Patients post liver transplantation

• Patients with concurrent or prior HCC (LR-5 or biopsy proven)

• other liver cancer including cholangiocarcinoma

• Patients with any active extra-hepatic malignancy

• Patients with significant comorbidity and limited life expectancy, e.g., stage D congestive heart failure, in whom surveillance is not warranted are also excluded given unlikely clinical benefit

• Patients with contraindication to contrast-enhanced MRI or CEUS, including implanted medical devices that are considered MR unsafe and severe claustrophobia

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• HCC
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• CEUS vs aMRI
Comparison between CEUS and aMRI

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early HCC Detection	Assess and compare true positive rate (TPR) and false positive rate (FPR) of AMRI to CEUS for early-stage HCC detection, as defined by the Barcelona Clinic Liver Staging system.	5 years
Secondary	HCC Detection	Evaluate TPR and FPR for any-stage HCC.	5 years
Secondary	Early HCC Detection	Assess and compare true positive rate (TPR) and false positive rate (FPR) of AMRI to CEUS for early-stage HCC detection, as defined by the Milan Criteria	5 years