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 个研究点目标入组 25 人开始时间: 2023年12月19日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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.
•- Scars that cannot be protected or wound clips, implants, or prostheses in the planned path of the ultrasound beam.

发起方

niversität zu Köln