Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma, Pancreatic Ductal

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Patients who received SOC and received IRE

Patients who received SOC and did not receive IRE

NanoKnife System

This multicenter, observational study will evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC). Eligible patients will be recruited over a 36-month period and participating institutions will enroll and provide data on consecutive patients that meet inclusion and exclusion criteria. Each patient will be followed up for the duration of the study or until death. The study will include two (2) cohorts: patients who received standard of care (SOC) and received irreversible electroporation (IRE) \[IRE cohort\], and patients who were treated with SOC and did not receive IRE \[SOC cohort\].

A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer

Registry to Evaluate Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma

To evaluate the effectiveness of the NanoKnife System when used for the ablation of Stage 3 PC in real world treatment settings, by testing the hypothesis that IRE with the NanoKnife System improves overall survival (OS)

Angiodynamics, Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All patients enrolled in this trial will receive IRE treatment with the NanoKnife System

IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.

Irreversible Electroporation

Jonathan Coleman, MD

Arvin George, MD

Pivotal study to evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients. This study will assess the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.

Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue

Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue in an Intermediate-Risk Patient Population

To determine the NanoKnife System's ablation effectiveness by measuring the negative in-field biopsy rate at 12 months

To determine the NanoKnife System's procedural and post-procedural safety profile by evaluation adverse event incidence, type, and severity through 12 months

Rate of negative in-field biopsy at 12 months as defined by the Delphi consensus criterion of absence of clinically significant disease (≤ 3 mm of Gleason ≤ 6 disease in any biopsy core is insignificant)

Assessment of urinary function by comparison of pre- and post-operative UCLA Expanded Prostate Cancer Index Composite (UCLA-EPIC) Urinary Domain and International Prostate Symptom Scores (IPSS) and IPSS Quality of Life2 (IPSS-QoL) scores.

Assessment of erectile function by comparison of pre- and post-operative 15-Item International Index of Erectile Function (IIEF-15) potency scores.

Effectiveness of therapy by measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir.

Assessment of changes in prostate volume by comparison of pre-treatment and 12-month prostate volume measured via mpMRI.

Assessment of ablation effectiveness by evaluation of prostate tissue by mpMRI at 3 to 10 days post-treatment and at 12 months post-treatment.

Assessment of need for secondary or adjuvant treatment following treatment with the NanoKnife System.

Evaluation of subject reported pre- and post-operative Quality of Life (QoL) using the 5-dimension scale EuroQol (EQ-5D®).

Antineoplastic Agents

Micronutrients

Irinotecan

Leucovorin

Fluorouracil

Oxaliplatin

Folfirinox

Chemotherapy regimen of leucovorin, fluorouracil, irinotecan, and oxaliplatin

Modified FOLFIRINOX Regimen

Elizabeth Manning

Govindarajan Narayanan, MD

Thanh Tran

Vic Velanovich, MD

Henry Mantakul

Malcolm Bilimoria, MD

Mary Healey

Janine Schippang

Darius Desai, MD

Misbah Shabbir

Patricio Polanco, MD

Subjects will be offered the opportunity to participate in a randomized, controlled, 2-arm, unblinded multicenter trial (RCT). There will be 2 study arms: the control arm receiving chemotherapy with the modified FOLFIRINOX regimen alone; and the irreversible electroporation (IRE) arm, receiving chemotherapy with the modified FOLFIRINOX regimen followed by IRE with the NanoKnife System using either an open or a percutaneous approach. All subjects will be treated with the modified FOLFIRINOX regimen for at least 3 months; randomization to either control or IRE arm will take place at the time of completion of the 3 month modified FOLFIRINOX chemotherapy regimen. Randomization will be conducted centrally. Subjects will be randomized in a 1:1 ratio and must be found to have no evidence of disease progression after completion of the 3 month modified FOLFIRINOX chemotherapy regimen in order to participate in the RCT. All radiologic assessments will be performed as consistent with the imaging protocol. All post induction and post IRE treatments are left to the discretion of the treating physician. The minimum period of follow-up will be for 24 months or until death.

A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer

A Randomized, Multicenter, Controlled, Unblinded Study to Assess the Safety and Efficacy of the NanoKnife® System for the Ablation of Unresectable Stage 3 Pancreatic Adenocarcinoma

Time (in months) from randomization to the date of death for any reason

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer	NCT03899649	Stage III Pancr...	SOC NanoKnife Syste...	18 Years -	Angiodynamics, Inc.
Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue	NCT04972097	Prostate Cancer	Irreversible El...	50 Years -	Angiodynamics, Inc.
A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer	NCT03899636	Stage III Pancr...	Modified FOLFIR... NanoKnife Syste...	18 Years -	Angiodynamics, Inc.
A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer	NCT03899649	Stage III Pancr...	SOC NanoKnife Syste...	18 Years -	Angiodynamics, Inc.
A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer	NCT03899636	Stage III Pancr...	Modified FOLFIR... NanoKnife Syste...	18 Years -	Angiodynamics, Inc.

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