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TLC: Indeterminate Liver Nodules

Primary Investigator
Parikh, Neehar
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT06184152
UM Number
2024.118
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Cancer Control and Prevention
ID (Protocol)
59201
Secondary Protocol No
HUM00241135
Scope
Unspecified
Sponsor Type
Externally Peer-Reviewed
Disease Site
Liver
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.

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