Early Feasibility Study to Evaluate the Initial Safety and Device Functionality of VectRx Thermal Therapy Added to Chemotherapy Treatment of Pancreatic Tumors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Cancer
- Sponsor
- NeoTherma Oncology
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Safety of the VectRx treatment evaluated by incidence of Adverse events (AEs) such as first and second-degree burns, edema and abdominal pain, will be assessed [safety and tolerability].
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provide signed and dated informed consent form
- •Subjects who are \> 18 years old
- •Histologically or cytologically proven adenocarcinoma of the pancreas
- •Subjects who enrolled prior to- or during initial course of planned chemotherapy.
- •Subjects with other histology that would typically receive these regimens are included (i.e. adenosquamous)
- •BR and UR Pancreatic Cancer based on modified NCCN guideline will be used as a guide for radiographic findings (94), or high risk resectable pancreatic cancer recommended by a multi-disciplinary team for chemotherapy based on NCCN recommendations (NCCN version 2.2021).
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies CT
- •Eastern Cooperative Oncology Group (ECOG) performance of 0-1 (Appendix D)
- •Estimated life expectancy \> 9 months
- •If female patient is of child-bearing potential, she must have a negative serum pregnancy test (βhCG) documented at screening
Exclusion Criteria
- •Subjects with any part of the body between the hips and shoulders \>46 inch circumference, with an anterior posterior depth of \~10.5" in a supine position (fit may vary with body shape)
- •Subjects unable to tolerate magnetic resonance imaging
- •Subjects receiving treatment with other radiofrequency medical devices
- •Subject has pacemaker, electrocardiograph, implanted defibrillator, infusion pumps, insulin pumps, cardiac monitoring electrodes and devices, deep brain stimulators, cochlear implants, radiofrequency identification devices attached to devices, or any implanted active electronic device or monitoring system, adhesive skin patches including conductive metal
- •Metal biliary stents (plastic stents are allowed)
- •Non-removable implanted designated MR unsafe and/or RF incompatible ferromagnetic metallic devices such as metal joint replacements
- •Subjects who have ferromagnetic or electrically conductive, metal, or foreign objects in or on or attached to their body
- •Severe pulmonary disease with a forced expiratory volume (FEV) \<50%
- •Unstable angina pectoris (under medication) with imminent threat of an infarction
- •Myocardial infarction \<6 months ago
Outcomes
Primary Outcomes
Safety of the VectRx treatment evaluated by incidence of Adverse events (AEs) such as first and second-degree burns, edema and abdominal pain, will be assessed [safety and tolerability].
Time Frame: 3 months
AEs including serious adverse events (SAEs), including 1st degree and 2nd degree burns, edema, and abdominal pain will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5 November 2017) during each heat therapy (HT) and chemotherapy (CT) treatment.
Performance of the VectRx device in its ability to increase temperature in the pancreas
Time Frame: 3 months
Temperature change in patient internal and surface temperature probes measured in degree Celsius during each heat therapy (HT)