Histotripsy Demonstrates Technical Success, Safety for Primary and Metastatic Liver Tumors

Results from the #HOPE4LIVER Trials

The prospective, multicenter, single-arm #HOPE4LIVER trials, parallel studies taking place in the United States and the European Union and England, met their coprimary end points, confirming the technical success and safety of histotripsy among patients with primary and metastatic liver tumors.
 
Histotripsy is a novel technique that uses cavitation to induce mechanical breakdown of tissue at the focal point of liver tumor. This technique is nonthermal, nonionizing, and noninvasive. In preclinical trials, histotripsy has shown safety and technical success for the ablation of tumors in the liver.
 
In these trials, there were 44 patients with up to 3 liver tumors, smaller than 3 cm in size, with a total 49 tumors, were enrolled to receive ablation with histotripsy. There were 18 patients with hepatocellular carcinoma, and 26 patients with non-hepatocellular carcinoma liver metastases. Patients underwent CT or MRI imaging and clinic visits at 1 week or less before the procedure, at index-procedure, 36 hours or less after the procedure, and 30 days after the procedure. The co-primary end points were technical success of tumor treatment and absence of procedure-related major complications within 30 days.
 
Of the 44 treated tumors, technical success was reported in 42 (95%). Procedure-related complications within 30 days were reported in 3 of 44 patients (7%). Both these results met the prespecified performance goals of >70% and <25%, respectively.
 
According to the study authors, these results demonstrate “the ability of histotripsy to treat a targeted volume of liver tissue successfully and safely.” They added, “Pending early clinical adoption, larger trials with longer follow-up in typical candidates for local-regional treatment with provide further outcome data to help define the role of this emerging technology.”

Source:

Mendiratta-Lala M, Wiggermann P, Pech M, et al. The #HOPE4LIVER single-arm pivotal trial for histotripsy of primary and metastatic liver tumors. Radiology. Published online: September 3, 2024. doi:10.1148/radiol.233051.