Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Patient with HCC and decision of treatment with ablation

Hepatic Percutaneous Ablation with radiofrequency or microwave

Percutaneous ablation

Julien GUELFI, PH

This cohort study compares immune response induced in two groups of small HCC patients treated by ablation (group1 RFA, group 2 MWA). Patients will benefit for tumoral and non tumoral biopsies prior to treatment and stepped peripheral blood samples juste before ablation and during the first month after.

Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma

Comparison of modulation of immune cells (frequency, activity, function) between the two groups. Study of immune cells will include T cells with immune checkpoints molecules (PD-1+ CD8+ T, 4-1BB+ CD8+ T, LAG-3+ CD8+ T, Tim-3+ CD8+ T, COS+ CD8+ T) before and after the treatment (day 0, day 2, day 7, day 30)

Differences of frequencies, activities, functions of immune cells before and after the RFA treatment (day 0, day 2, day 7, day 30). Study of immune cells will include T cells with immune checkpoints molecules (PD-1+ CD8+ T, 4-1BB+ CD8+ T, LAG-3+ CD8+ T, Tim-3+ CD8+ T, COS+ CD8+ T)

Differences of frequencies, activities, functions of immune cells before and after the MWA treatment (day 0, day 2, day 7, day 30). Study of immune cells will include T cells with immune checkpoints molecules (PD-1+ CD8+ T, 4-1BB+ CD8+ T, LAG-3+ CD8+ T, Tim-3+ CD8+ T, COS+ CD8+ T)

University Hospital, Grenoble

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Single arm study: Percutaneous irreversible electroporation of locally advanced pancreatic carcinoma

Tumor ablation with irreversible electroporation with the NanoKnife

NanoKnife "Irreversible electroporation (IRE)"

Martijn R Meijerink, MD, PhD

Geert Kazemier, Prof. Dr.

Cornelis van Kuijk, Prof. Dr.

Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeostasis.

The purpose of this study is to investigate the safety of percutaneous IRE in the treatment of patients with locally advanced pancreatic carcinoma (LAPC). Other objectives are feasibility and efficacy of IRE based upon symptomatic response and tumor response.

Fourty patients with histologically confirmed locally advanced pancreatic adenocarcinoma (\<5cm) will undergo percutaneous irreversible electroporation of the tumor using CT and ultrasound guidance. After IRE, patients will be carefully monitored and any (serious) adverse events are registered. Follow-up will consist of frequent CT scanning, as well as serum CA19.9 tumor marker.

We hypothesize that IRE in the pancreas will induce good symptom palliation and local tumor control, without causing severe complications.

PANFIRE Study: Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma

PANFIRE - Pilot-study: Non-thermal Ablation Using Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma - a Phase I Clinical Trial

Number of adverse events of IRE-treatment (within 12 months after treatment) are registered and analyzed according to the CTCAE version 4.0. Complications related to IRE are early complications during hospital admission (e.g. bile leak, bowel leak, infection, pancreatitis), or late complications of IRE such as bile duct stenosis that become apparent during follow-up in the year after treatment.

* Ablation success: the ability to deliver the planned therapy and at 3 months to have no evidence of residual tumor;
* Local recurrence rate (LRR): defined as the reappearance of viable tumor after a period of time during which viable tumor could not be detected;
* Overall survival and (local and distant) progression-free survival.

Amsterdam UMC, location VUmc

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasm Metastasis

Lung Neoplasms

Neoplastic Processes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients will be treated with IRE ablation directed at the target lesion on day 1. Moderate-dose, single-fraction radiation therapy will be delivered to the target lesion on day 8 to day 15.

IRE will be performed using the NanoKnife or Aliya System. CT or cone-beam CT will be used to direct electrode placement.

Irreversible electroporation (IRE) ablation

Moderate-dose radiation therapy to the target tumor(s) in 1 fraction.

Radiation Therapy

Jeremy Harris, MD

This is a phase 0, pilot prospective study to determine the feasibility of combined irreversible electroporation (IRE) and radiation therapy in subjects with lung tumors with metastatic cancer of any histology. These are subjects who have advanced disease (stage IV) or previously treated disease that has become progressive, recurrent, or metastatic.

A Novel Method for Treating Lung Met w/Combo of Electric Fields & Rad Therapy: A Single-Arm

A Novel Method for Treating Lung Metastases With the Combination of Electrical Fields and Radiation Therapy: A Single-Arm Pilot Study

Number of patients completing treatment of both IRE and the single fraction of radiation. Up to 6 replacements are allowed (total subjects 6-12)

Severe toxicity will be measured by cumulative CTCAE v5.0 grade 3-5 events. Evaluation of Grade 3-5 toxicity will be made at 30 days

Local failure rate at the treated site will be determined using cumulative incidence rates with death as a competing event at 12 months after initiation of treatment

The duration of response is measured from the time of treatment initiation until local failure is objectively documented

Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Estimates at 6 and 12 months will be made.

The duration of time from start of treatment to time of progression or death, whichever occurs first. Estimates at 6 and 12 months will be made.

Toxicity will be measured by cumulative CTCAE v5.0 grade 1-5 events. Evaluation of Grade 1-5 toxicity will be made at 30 days

Mean summary score of the Functional Assessment of Cancer Therapy-Lung (FACT-L). Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale is a 36-item self-reported instrument that measures multidimensional quality of life for lung cancer patients. Questions are scored on a 5-point Likert Scale. The FACT-L includes the FACT-G (general) assessment which is comprised of four subscales including Physical Well-Being (score = 0-28), Social/Family Well-Being (score= 0-28), Emotional Well Being (score = 0-24), and Functional Well-Being (score = 0-28), for a total score min/max = 0-108, plus, the Lung Cancer Subscale (nine lung cancer related items, score = 0-45). Total scores range from 0-136, with higher scores indicating better quality of life.

Pulmonary function is assessed by the volume change (mL) in the value of forced vital capacity (FVC)

Pulmonary function is assessed by volume change (mL) in the value of forced expiratory volume at 1 second (FEV1)

Pulmonary function is assessed by change in the value of diffusing capacity for carbon monoxide (DLCO) measured in mL/min/kPa

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma	NCT04892810	Hepatocellular ...	Percutaneous ab...	40 Years -	University Hospital, Grenoble
PANFIRE Study: Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma	NCT01939665	Locally Advance... Non-metastasize... Pancreatic Canc...	NanoKnife "Irre...	18 Years -	Amsterdam UMC, location VUmc
A Novel Method for Treating Lung Met w/Combo of Electric Fields & Rad Therapy: A Single-Arm	NCT05555342	Lung Tumor Metastatic Canc...	Irreversible el... Radiation Thera...	18 Years -	University of California, Irvine
A Novel Method for Treating Lung Met w/Combo of Electric Fields & Rad Therapy: A Single-Arm	NCT05555342	Lung Tumor Metastatic Canc...	Irreversible el... Radiation Thera...	18 Years -	University of California, Irvine

Spots Global Cancer Trial Database for percutaneous ablation