Key Points
- At least 17 ongoing worldwide clinical trials are testing focused ultrasound for the treatment of pancreatic cancer.
- The studies each take a novel approach and use a variety of clinical systems.
There are currently at least 17 ongoing global focused ultrasound clinical trials for treating pancreatic cancer. Some examples are described below.
South Korea and the United States: As follow-up to a Phase II pilot trial, a randomized, Phase III pivotal clinical trial (NCT07325214) is evaluating whether focused ultrasound plus standard FOLFIRINOX chemotherapy improves outcomes for patients with borderline resectable or locally advanced pancreatic cancer. Participants are randomly assigned to receive chemotherapy alone or chemotherapy plus focused ultrasound, with researchers comparing safety, tumor response, progression-free survival, overall survival, and the likelihood that tumors become surgically removable. The study is being led by Jae Young Lee, MD, PhD, and aims to determine whether focused ultrasound can enhance the effectiveness of chemotherapy by improving drug delivery to the tumor and ultimately increase the chances of successful surgery and long-term survival. The trial is sponsored by IMGT Co., Ltd., using the IMD10 focused ultrasound system, and is expected to enroll approximately 290 participants at two sites in South Korea and three in the US (Massachusetts, Texas, and Virginia).
Spain: In 2024, HistoSonics launched the first clinical trial to test the use of histotripsy for pancreatic cancer treatment. The GANNON trial (NCT06282809) is evaluating the Edison system, which uses image-guided sonic beam therapy to noninvasively and mechanically destroy pancreatic tumors. Led by principal investigator Santiago Sanchez Cabús, MD, PhD, MSc, the trial aims to enroll up to 30 participants with unresectable pancreatic adenocarcinoma (stage 3 or 4) at Hospital de Sant Pau in Barcelona.
Japan: SONIRE recently completed enrollment in a clinical trial (NCT05601323) using focused ultrasound to enhance chemotherapy in patients with unresectable pancreatic cancer. The Suizenji system uses cavitation bubbles that increase heating efficiency, enabling effective thermal therapy with lower acoustic energy. The bubbles also aid in visualizing the treatment area on ultrasound imaging. The trial, which enrolled 90 participants, is assessing whether participants who received high-intensity focused ultrasound (HIFU) therapy in addition to chemotherapy experience prolonged survival when compared with participants who received chemotherapy alone.
United States: An early-phase, single-arm feasibility study (SUNRISE-II, NCT07033689) will evaluate SONIRE’s Suizenji system in patients with newly diagnosed, unresectable pancreatic ductal adenocarcinoma. Participants will receive one or more HIFU treatments to ablate at least 50% of the primary tumor before beginning standard first-line chemotherapy. Investigators will be assessing the procedure’s safety and technical success, and whether there are any preliminary signs of clinical benefit. Tumor response, pain relief, immune effects, progression-free survival, and overall survival will also be used to determine whether this noninvasive approach warrants a larger clinical trial. Led by principal investigator Pejman Ghanouni, MD, PhD, the study plans to enroll 10 participants at Stanford Cancer Institute.
Germany: Researchers at University Hospital/Universitätsklinik Bonn are conducting a pancreatic cancer clinical trial comparing the combination of focused ultrasound and chemotherapy with standard systemic chemotherapy alone (German Clinical Trial Registry DRKS00012367). Led by Prof. Milka Marinova, MD, PhD, and Prof. Maria Gonzalez-Carmona, MD, the clinical trial in Bonn is open to patients who have been newly diagnosed with inoperable pancreatic cancer. This two-arm, randomized, controlled trial aims to evaluate the added benefit of local HIFU performed using the ultrasound-guided Chongqing HAIFU system, following the first cycle of standard-of-care systemic chemotherapy. A total of 70 participants (35 per treatment arm) will be enrolled.
Germany: A safety and feasibility clinical trial at Universitätsklinik Köln is using the Sonalleve MR-HIFU system (Profound Medical Corp.) to ablate locally advanced, nonresectable, or metastatic pancreatic cancer in patients with stable disease who have after completed first-line chemotherapy (German Clinical Trial Registry DRKS00033237). The HIFU ablation is applied to the primary tumor before the participant begins the subsequent several cycles of chemotherapy. The safety of the treatment along with its impact on pain control, quality of life, and progression-free survival will be analyzed. Eleven of 25 participants in this research study have now been enrolled. The clinical trial is being led by Dirk-Thomas Waldschmidt, MD.
United Kingdom: An ancillary research study (ISRCTN56087634) in the United Kingdom aims to measure the immune response induced by focused ultrasound ablation for pancreatic cancer. The study, led by Srikanth Reddy, MD, PhD, is analyzing blood samples from patients who underwent HIFU treatment as part of an ongoing, separately funded clinical trial to treat locally advanced pancreatic cancers that are not suitable for surgery. Blood samples were drawn before and after the HIFU procedure. This early-phase study, which is now closed to enrollment and awaiting publication, will provide preliminary data to power future studies.
United States and United Kingdom: A Phase II clinical trial (NCT06850623) is using focused ultrasound to augment the penetration of chemotherapy in patients with locally advanced pancreatic cancer. The trial, called ENACT, is testing Exact Therapeutics’ Acoustic Cluster Therapy (ACT®), a novel, ultrasound-mediated technology platform for delivering targeted therapeutics. This study is unique in that it uses both high-frequency focused ultrasound (for creation of the larger ACT® bubbles) and low-frequency focused ultrasound (to increase penetration of chemotherapy into the tumor) during each treatment. Twenty-five participants who have not received prior treatment for their pancreatic cancer will undergo up to eight two-week cycles of chemotherapy. Participants will have CT scans every eight weeks to assess changes in tumor size, and researchers will assess overall survival and monitor whether the tumors shrink enough to make them eligible for surgical resection. The trial is currently enrolling at seven US sites in Arizona, California, Massachusetts, Michigan, Pennsylvania (two sites), and Rhode Island—and at three sites in the United Kingdom.