Evaluation of Sonalleve MR-HIFU for Ablation of Locally Advanced Non-resectable and Metastatic Pancreatic Cancer in Patients with Non-progressive Disease under First-line Chemotherapy: Feasibility and Safety Clinical Study [HIFU-PANC] - HIFU-PANC

niversität zu Köln0 sites25 target enrollmentDecember 19, 2023

Overview

No summary available.

Registry

who.int

Start Date

December 19, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

niversität zu Köln

•Histological or cytological confirmed unresectable ductal adenocarcinoma of the pancreas (PDAC) (AJCC stage IIIb, IV) with no prior surgical resection.
•\- Patients need to receive standard of care (SOC) chemotherapy and must not show any signs of progression after 3 months of chemotherapy (at least stable disease).
•\- Patients must be eligible for MR imaging and MR\-HIFU sessions.
•\- PDAC identifiable, targetable, and reachable in MRI for treatment.
•Patients need to be eligible for SOC chemotherapy with adequate renal, hepatic and bone marrow function

•\- Treatment target zone \< 10mm from the skin.
•\- Body weight \> 140 kg
•\- Any MR\-unsafe implant or pacemaker. Any MR\-conditional implant that requires scanning with less than 3 Tesla or adjustments to the scan protocol
•\- Patients with contraindication to Buscopan (Hyoscine).
•\- Major surgical interventions within 4 weeks before study enrolment . Wound healing must be also completed before first application of study treatment.
•\- Medical history of interstitial lung disease (ILD) or pulmonary fibrosis.
•\- Hypersensitivity against any chemotherapeutic drugs administered as SOC
•\- Active or uncontrolled bacterial, viral, or fungal infection that requires systemic treatment.
•\- Abnormal coagulation and current anticoagulant therapy.
•\- Any other disease and condition that would contraindicate MR\-HIFU treatments and MR scans such as metal stents or other metal implants in the vicinity of treatment site, pacemakers, claustrophobia etc. and known allergies to contrast agents.