The first participant has been enrolled in a clinical trial to test Sonire Therapeutics’ ultrasound-guided focused ultrasound system for the treatment of pancreatic cancer.
The research study, called SUNRISE-II (NCT07033689), is assessing the safety and feasibility of using Sonire’s high-intensity focused ultrasound (HIFU) system to deliver localized thermal ablation to primary pancreatic tumors that cannot be surgically removed (or “resected” in surgical terms). The purpose of the focused ultrasound is to thermally ablate the tumor.
A total of 10 participants will be enrolled at Stanford University by principal investigator Pejman Ghanouni, MD, PhD, a radiologist who directs Stanford Medicine’s Minimally Invasive MR Interventional Center and the Focused Ultrasound Center of Excellence.
In the clinical trial, participants will undergo focused ultrasound treatment before the initiation of a standard first-line chemotherapy. The chemotherapy regimen will begin within two weeks after the focused ultrasound is applied. Participants return for follow-up visits one month and three months after treatment begins.
Unresectable pancreatic ductal adenocarcinoma varies in stage and extent. Even if it is confined to the pancreas and nearby structures, if it has reached the surrounding blood vessels, it is considered locally advanced and inoperable. If safety is confirmed, this approach could be tested in larger clinical trials in the future.
“Treatment options for pancreatic cancer remain extremely limited due to the complexity and location of the disease,” said Tohru Satoh, President and CEO of Sonire Therapeutics in the company’s press release. “Initiating SUNRISE-II in the United States is a defining milestone for our company. It enables us to begin building clinical evidence in a new market while advancing a treatment approach designed to be less invasive and more accessible for patients.”
In 2023, Sonire launched a similar clinical trial in Japan, and the results of that study are being closely watched. Sonire’s HIFU platform has also received Breakthrough Device Designation from the United States Food and Drug Administration.