The #HOPE4LIVER trials, testing the safety efficacy of histotripsy as a treatment for primary and metastatic liver tumors, met its goals for technical success and safety.
The result, published in Radiology, supports early clinical adoption for the procedure.
Histotripsy is a noninvasive procedure that uses focused ultrasound to mechanicallybreak down tumors.
The technology was pioneered by University of Michigan faculty and students over the prior three two decades.
Histotripsy received FDA approval late 2023 as an alternative to traditional forms of liver directed cancer treatments.
“We feel fortunate to have treated the most patients in the trial, since the technology was discovered at our university,” said Mishal Mendiratta-Lala, M.D., clinical professor of radiology at the University of Michigan and lead principal investigator of the trial.
“These results are very encouraging, and our multidisciplinary approach will hopefully continue to improve the care of liver cancer patients.”
About the trial
Forty-four participants with 49 tumors were enrolled in the #HOPE4LIVER trial between the United States and Europe.
After treatment, technical success was achieved in 95% of cases (42 of 44), eclipsing the performance goal of 70%.
In addition, three of the 44 cases reported a procedure-related major complication, below the 25% goal for safety, of which at least two may have been cancer related and not device related, as reported by Mendiratta-Lala.
Around half of all patients with colorectal cancer experience spread to their liver, but local treatment options such as thermal ablation and radiation have traditionally contained a variety of risks and limitations, and surgical resections are invasive procedures with complications and long recovery.
By virtue of being noninvasive and using soundwaves, histotripsy can overcome some of these limitations.
The 95% success rate reported in this trial compared favorably to other local techniques for treating liver tumors, while the 7% complication rate fell within reported ranges for other local techniques.
"I am very excited to see the highly promising clinical trial results of patients with liver tumors treated by histotripsy, which was invented in our lab 20 years ago,” said Zhen Xu, Ph.D., U-M professor of Biomedical Engineering, Radiology, and Neurosurgery.
“I hope that the non-invasive nature, high precision, and capability to spare critical vessels and bile ducts will really improve the treatment for patients with primary and metastatic liver tumors, and many other tumor types in the future."
Researchers expect these results will lead to early clinical adoption, larger trials, and more detailed data on long term outcomes.
Currently University of Michigan department of radiology has partnered with hepatobiliary surgery in a multidisciplinary approach to treat patients with primary and metastatic liver cancer.
Additional authors: Philipp Wiggermann, Maciej Pech, Xavier Serres-Créixams, Sarah B. White, Clifford Davis, Osman Ahmed, Neehar D. Parikh, Mathis Planert, Maximilian Thormann, Zhen Xu, Zachary Collins, Govindarajan Narayanan, Guido Torzilli, Clifford Cho, Peter Littler, Tze Min Wah, Luigi Solbiati, Timothy J. Ziemlewicz
Disclosures for Mendiratta-Lala: Support for attending meetings from HistoSonics; ACR and SAR LI-RADS Treatment Response Working Group chair.
General disclosure: U-M retains a financial interest in HistoSonics, the system used in this trial, as do a number of researchers who were involved in this project and who helped develop the technology licensed to HistoSonics. Each stands to benefit financially from the success of the platform. The company was formed with support from Innovation Partnerships, U-M’s central hub for research commercialization.
Paper cited: “The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors,” Radiology. DOI: 10.1148/radiol.233051
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