A Study to Evaluate the NanoKnife SYstem for Stage 3 Pancreatic Cancer

Overview

Información sobre este estudio

The purpose of this study is to evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC). 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Provisions of signed and dated informed consent form.
  • Patient is 18 years of age and older.
  • Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria.
  • Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery.
  • Maximum axial and anterior to posterior tumor dimension of ≤ 3.5cm after SOC.
  • Patient has received 3 months of SOC per each participating institution’s guidelines.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1, 2, 3 or 4.
  • Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System.
  • Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC.

Exclusion Criteria:

  • Participation in an interventional trial for pancreatic cancer during the study data collection period.
  • Pregnant or lactating patients or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy.
  • Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade.
  • Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Rory Smoot, M.D.

Cerrado para la inscripción

Contact information:

Kimberly Nuhanovic CCRP

(507) 293-3905

Evatt.Kimberly@mayo.edu

Jacksonville, Fla.

Investigador principal de Mayo Clinic

John Stauffer, M.D.

Cerrado para la inscripción

Contact information:

Mauricia Buchanan R.N.

Buchanan.Mauricia@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20509963

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