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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06184152
Other study ID # 1U01CA283935
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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