Multicenter Prospective Study Using Fluctuational Imaging to Diagnose Liver Hemangioma with Ultrasound

What this Trial Is About

Hepatic hemangioma is the most common benign liver tumor, seen in up to 20% of people. Typical ultrasound shows it as a bright lesion, but this is only true in about 70% of cases. Other ultrasound features may help, but often contrast-enhanced CT or MRI is needed for a clear diagnosis. Researchers are studying Fluctuational Imaging FLI, a new computer-based ultrasound method that measures tiny movements within the lesion, aiming to improve diagnosis accuracy and reduce the need for CT or MRI scans. This exploratory, multicenter study will enroll about 400 adults with liver lesions 1 cm or larger. Participants will undergo FLI ultrasound, and their lesions will be classified as hemangioma or other liver tumors using established standards. Four independent readers will review the FLI results to determine if the lesions show positive fluttering signs. The study will compare FLI positivity between hemangioma and non-hemangioma groups and explore how lesion brightness and depth affect FLI performance. Participants will have a single FLI ultrasound exam, with images anonymized for expert review. The main measurement is the presence of FLI-positive findings during the procedure. Secondary measurements include lesion brightness and depth. The study involves no additional risks beyond routine ultrasound. Results may help reduce unnecessary CT or MRI scans, lowering costs and exposure to radiation or contrast agents. The study expects to complete by the end of 2026.

Fluctuational Imaging for the Diagnosis of Hepatic Hemangioma: A Multicenter, Prospective Study