Key Points
- The first participants have been treated in two new German clinical trials using focused ultrasound to treat pancreatic cancer.
- The studies are each taking a different approach to this devastating disease.
In Bonn, Germany
Researchers at University Hospital/Universitätsklinik Bonn are conducting a pancreatic cancer clinical trial that is comparing the combination of focused ultrasound and chemotherapy with standard systemic chemotherapy alone. The clinical trial is led by Prof. Milka Marinova, MD, PhD, and Prof. Maria Gonzalez-Carmona, MD (German Clinical Trial Registry DRKS00012367). In the past, focused ultrasound has mainly been used to relieve symptoms in patients with advanced pancreatic cancer who have exhausted all other treatment options. But this clinical trial in Bonn is open to patients who have been newly diagnosed with inoperable pancreatic cancer. The goal of this two-arm, randomized, controlled trial is to evaluate the added benefit of local high-intensity focused ultrasound (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. The study will assess key outcomes, including tumor volume, cancer-related pain, quality of life, as well as progression-free and overall survival. The Foundation is currently funding the participation of 20 patients enrolled and could provide additional support pending the interim analysis.
In Köln, Germany
A clinical trial at Universitätsklinik Köln is being led by Dirk-Thomas Waldschmidt, MD, and Holger Grüll, PhD. In this feasibility and safety study, the Sonalleve MR-HIFU system (Profound Medical Corp.) is being used to ablate locally advanced, nonresectable or metastatic pancreatic cancer in patients with stable disease after completing first-line chemotherapy (German Clinical Trial Registry DRKS00033237). The HIFU ablation is applied to the primary tumor before the participant begins the next 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. Researchers are particularly interested in determining whether thermal ablation of the primary tumor is technically feasible. Six of 25 participants in this research study have now been enrolled. The Association of Internal Oncology (AIO) has recently labeled this clinical trial an ‘AIO-associated study.’
“These two clinical trials will illuminate some of the issues raised at the Foundation’s November 2024 pancreatic cancer workshop,” said Tim Meakem, MD, one of the Foundation’s managing directors and co-director of the Research and Education Team. “Specifically, Dr. Marinova’s trial may show that using HIFU early in the patients’ treatments could produce better outcomes and prompt the widespread use of HIFU earlier in the course of the disease. Drs. Waldschmidt and Grüll are using an MRI-guided system that has technical improvements to that can give enhanced visibility of the tumor, compared to prior versions of the device.”
For Patients
To inquire about participation in one of these clinical trials, contact the enrollment center investigators.
- At Universitätsklinik Bonn: Dr. Patrick Jim Küppers (patrick_jim.kueppers@ukbonn.de)
- At Universitätsklinik Köln: Dirk-Thomas Waldschmidt (Gastroenterologie-Studien@uk-koeln.de)