Overview

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.

Eligibility

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
• Subjects who meet the following baseline organ function parameters:
  • Absolute neutrophil count >/= 1,500cells/mm3
  • Platelets >100,000cells/mm3
  • Total Bilirubin ≤1.5X normal institutional limits OR < 2.0 ULN if stenting occurred
  • AST(SGOT)/ALT(SGPT) <2.5X institutional upper limit of normal
  • Creatinine < 1.5mg/dl OR Cr clearance >60 mL/min/1.73 m2
• Subjects with inactive/asymptomatic carrier, chronic, or active HBV infection must

  meet the following criteria: HBV deoxyribonucleic acid (DNA) < 500 IU/mL (or 2500 copies/mL) at screening. Subjects with cured hepatitis C virus (HCV) infection at screening can be enrolled but should have HBV DNA levels checked periodically while on study to monitor for reactivation.

        Eligible HBV: HB sAg(-) HB sAg (+) and DNA < 500 IU/mL (or 2500 copies / mL) HCV: HCV Ab
        (-) HCV Ab (+) and HCV RNA (-)
        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
          -  Cardiac decompensation or arrhythmia necessitating medication
          -  Systolic blood pressure >180 mmHg and/or <90 mmHg, while using medication
          -  Diastolic blood pressure >100 mmHg and/or <50 mmHg, while using medication
          -  Open skin wounds on the torso
          -  Severe cerebrovascular disease: multiple cerebrovascular accidents (CVA) or a CVA <6
             months before treatment
          -  Subjects having received prior pancreatic surgery, radiation therapy, for pancreatic
             cancer of any histology
          -  Subjects with tumors extending to or invading the duodenum
          -  Subjects with recurrent/relapsed pancreatic cancer
          -  Progressive disease on pre-protocol enrollment studies for patients already on
             systemic therapy
          -  Subjects with pancreatitis
          -  Subjects in their reproductive age who are breast feeding or have a positive pregnancy
             test
          -  Any co-morbid condition such as but not limited to congestive heart failure, cardiac
             arrhythmia, or psychiatric illness of sufficient severity to limit full compliance
             with the protocol per assessment by the individual treating physician
          -  Concurrent active infection
          -  Prior malignancies other than cervical cancer in situ, adequately treated basal cell
             or squamous cell carcinoma of skin or treated low risk prostate cancer within the past
             3 years
          -  Patient with known historical or active infection with HIV
          -  Subjects with inactive/asymptomatic carrier, chronic, or active HBV infection with HBV
             deoxyribonucleic acid (DNA) > 500 IU/mL (or 2500 copies/mL) at screening
          -  Patient who has undergone recent major surgery, other than diagnostic surgical
             procedure within 4 weeks prior to screening
          -  Subjects with a history of interstitial lung disease, history of slowly progressive
             dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary
             fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
          -  Subjects with greater than grade 2 peripheral neuropathy
          -  History of any psychiatric condition that might impair the patient's ability to
             understand or comply with the requirement of the study or to provide consent
          -  Inability or unwillingness to provide informed consent
          -  Currently enrolled in another investigational drug or device trial that clinically
             interferes with this study.