Key Points
- A clinical trial in France will test EDAP’s new high-intensity focused ultrasound device for treating patients with pancreatic cancer.
- Patients with locally advanced, unresectable pancreatic adenocarcinoma are eligible for the research study.
EDAP recently announced the enrollment of the first patient in a new clinical trial in France (NCT06211933) using high-intensity focused ultrasound (HIFU) to treat pancreatic cancer.
The open-label, phase I/II study, called PULS, will take place in two stages. In phase I, up to six participants will be enrolled and treated to establish that the procedure is safe. If safety is determined, phase II will continue enrollment up to 26 total participants to measure efficacy.
Patients with a locally advanced, unresectable pancreatic adenocarcinoma that has previously been treated with chemotherapy are eligible for the research study. The clinical trial is being led by Professor Aurélien Dupré, MD, PhD, a surgical oncologist at the Centre Léon Bérard in Lyon, France. At least one additional site in France is also expected to enroll participants.
EDAP, under the brand of Focal One, is using a new platform for this clinical trial. After the pancreas is accessed via open surgery, HIFU is applied with a hand-held probe equipped with ultrasound imaging guidance. This proprietary toroidal transducer was tested in preclinical studies.
“For patients diagnosed with locally advanced pancreatic cancer, the standard treatment is chemotherapy with or without radiotherapy,” said Prof. Dupré. “The low proportion of patients who can benefit from surgery, and the scarcity of alternative therapies, make the development of new treatments vital and urgent. HIFU has the potential to provide a solution for these patients.”
“This first treatment milestone is the result of a strong collaboration between our product and clinical development teams as well as our strategic research and clinical partnerships,” said Ryan Rhodes, EDAP’s chief executive officer. “This demonstrates our on-going technical and clinical leadership in applying focused ultrasound therapy in areas of significant unmet need.”
More Information For Patients
For more information about the trial, visit clinicaltrials.gov and contact one of the locations listed.