Pancreatic Cancer Clinical Trial
Official title:
Early Feasibility Study to Evaluate the Initial Safety and Device Functionality of VectRx Thermal Therapy Added to Chemotherapy Treatment of Pancreatic Tumors
In this study, tumors of the pancreas are treated with a device placed around the abdomen that creates an electromagnetic field that generates heat in the tumor. Heating the tumor improves blood flow and the delivery of chemotherapy to the tumor as has been shown in numerous studies for various cancers with potential clinical benefits. Subjects will receive the thermal treatment on the same day and prior to receiving standard of care chemotherapy for a total of 4 treatments. This study is an early feasibility study that aims to demonstrate the safety and the performance of the device.
NeoTherma Oncology (NTO) is evaluating the initial safety and device functionality of VectRx, a medical device that produces a locoregional thermal effect through a Radiofrequency (RF)- generated Electromagnetic Field (EMF). VectRx therapy is intended for use as added to standard of care chemotherapy treatment of pancreatic ductal adenocarcinoma (PDAC). This treatment is intended to improve perfusion and re-oxygenate in the tumor microenvironment (TME) of deep solid tumors. This study will enroll up to 5 subjects who will receive treatment with the VectRx device in conjunction with standard of care Chemotherapy. Safety will be evaluated by the type and severity of AEs while functionality (ability to heat) will be assessed using precisely placed temperature probes. Together these results will provide an initial assessment of safety and functionality. Up to 5 adult subjects with pancreatic adenocarcinoma (primary and metastatic) recommended for chemotherapy based on multi-disciplinary tumor board evaluation including borderline resectable (BR) or unresectable (UR) Locally Advanced Pancreatic Cancer (LAPC), high risk resectable patients felt to benefit from chemotherapy. ;
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