Liver Tumor FUS Histotripsy Trial Results: Treatment is Safe and Predictable

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Key Points

  • A new publication provides data to demonstrate that the first-in-human histotripsy treatment for liver tumors was safe and predictable in all eight patients.
  • The clinical trial was performed in Spain with HistoSonics’ prototype focused ultrasound system.
  • Larger clinical trials, called #HOPE4LIVER, are now underway in the US and Europe.

First-In-Man Histotripsy of Hepatic Tumors: The THERESA Trial, a Feasibility Study

A new publication provides data to demonstrate that the first-in-human histotripsy treatment for liver tumors was safe and predictable in all eight patients. The clinical trial (NCT 03741088), called the THERESA Study, was performed at three locations in Spain with HistoSonics’ prototype focused ultrasound system.

The phase 1, multicenter clinical trial enrolled 8 patients (median age 60.4 years) with 11 unresectable, end-stage primary (n=1) and metastatic (n=10) liver tumors. The metastases came from colorectal (5 patients), breast (1 patient), and bile duct (1 patient) cancers.

“We have seen in the THERESA trial an outstanding impact on patients,” said Joan Vidal-Jové, MD, PhD, the study’s principal investigator. “The response of the immune system shows us the tremendous possibilities of histotripsy technology to interact with immunotherapies.”

The treated tumors had an average diameter of 1.4 cm. Acute technical success, which was the study’s primary endpoint, was achieved in all procedures. There were no device-related adverse events, so the study also met its secondary endpoint, which was safety. After the eight-week follow-up period, the researchers noted that tumor marker measurements from two of the eight patients had continually declined after treatment.

Larger histotripsy clinical trials, called #HOPE4LIVER, are now underway at eight hospitals in the United States and six hospitals in Europe.

See the International Journal of Hyperthermia >
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