(Youngseok Park, Pixabay)
2 Feb. 2021. A clinical trial is underway assessing the safety of an experimental non-invasive ultrasound therapy to treat liver cancer. The trial is conducted by HistoSonics Inc. in Minneapolis, developer of a system using a treatment called histotripsy that sends ultrasound beams into a patient’s body.
Histotripsy employs ultrasound, a form of focused sonic wave that both provides an image to guide the treatment, and also delivers energy beams to destroy the target tumor tissue. HistoSonics says its technology — based on research at universities of Michigan and Wisconsin — sends ultrasound beams into tissue, where the focused sonic energy produces bubble clouds that form and disappear in microseconds. Energy from the bubble clouds destroys tumor cells and tissue without heat or incisions.
The company says its system first provides an image of the target, in this case a tumor in the liver. The system also sends test pulses into the liver tumor to gauge the amount of energy needed to produce effective bubble clouds, then delivers the ultrasound beams for destroying tumor cells and tissue.
HistoSonics cites data showing the number of people with primary liver tumors increased by 43 percent in the past 16 years, and is expected to grow by another 40 percent by 2030. The liver is also a leading site for cancer to metastasize or spread from other parts of the body, Yet, only 20 to 30 percent of people with liver cancer qualify for surgical removal of liver cancer, due to occurrence of multiple tumors, poor liver function, or other underlying health issues.
First trial patient received treatment today
The clinical trial aims to determine the technical feasibility of histotripsy in treating liver cancer and safety of the procedure. The study team is enrolling 45 patients at eight sites in the U.S. with liver cancer, either primary tumors or cancer that spread from other tumors. All participants will undergo the HistoSonics procedure; there’s no sham or comparison group. The company says the trial’s first patient underwent the procedure today at Tampa General Hospital in Florida, one of the trial sites.
The study team is looking primarily for technical success in removing the tumors, by assessing the histotripsy site within 36 hours following the procedure, and evidence of complications or adverse effects. The researchers are also following up after 30 days to find signs of tumor mass or nodules at the histotripsy site as evidence of efficacy.
HistoSonics CEO Mike Blue says in a company statement released through Cision, “We believe our non-invasive solution combined with the potential benefits of histotripsy’s novel mechanism of action, have the potential to change the experience for patients with solid tumors, and this study is the next step in building that evidence.”
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