Neoplasms

Digestive System Diseases

All Conditions

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Hematinics

Anesthetics

Liver Extracts

NEUWAVE Microwave Ablation System with AC software for patients undergoing a percutaneous ablation of a soft tissue liver lesion by an interventional radiologist.

NEUWAVE microwave ablation of soft tissue liver lesions will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.

Microwave Ablation

Prospective, single-arm, multicenter study that will generate clinical data using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion.

Prospective, single-arm, multicenter study that will generate clinical data on 100 adult patients using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion. AC software is a computed tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE Microwave Ablation System. AC imports images from CT scanners for display and processing during ablation procedures to assist physicians in identifying ablation targets, assessing optimal ablation probe placement, and confirming the adequacy of the ablation margin.

All ablations will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.

Ablation Confirmation Study

A Multicenter Study to Evaluate NEUWAVE Microwave Ablation System Using Ablation Confirmation in Patients With a Soft Tissue Liver Lesion

Ablation of the target lesion(s) according to the protocol and covered completely with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin)

Ablation of the target lesion(s) according to the protocol and covered completely with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin) as assessed by imaging at 6 weeks

How many days patients remain in the hospital after the ablation procedure

Ethicon, Inc.

Per the study protocol, only events that the site investigator determined to be device-related and/or procedure-related were captured within the study database as this was a post-market study. These events were evaluated from the time of first probe puncture (Day 0) through study completion (6 weeks).

Each participant underwent NEUWAVE microwave ablation using Ablation Confirmation software of at least one soft-tissue liver lesion in accordance with the study site's standard-of-care.

Microwave Ablation With Ablation Confirmation Software

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

Smoking Status

Erin Meyers

Each participant underwent microwave ablation using NEUWAVE and the Ablation Confirmation software for at least one soft-tissue liver lesion in accordance with the study site's standard-of-care

Percentage of Lesions Where Probe Repositioning is Suggested

Percentage of Lesions Where Re-ablation is Suggested

Technical Success

Technique Efficacy

Only 27 patients had this data available. When not collected, this was noted as a protocol deviation.

Hospital Resource Utilization

Overall Study

Symptoms and General Pathology

Hypertrophy

Pathological Conditions, Anatomical

* Each patient will undergo a total of 3 MRI/MRA scans (lasting 30-60 minutes):

  * Scan 1: Baseline (pre-portal vein embolization (PRE))
  * Scan 2: Early after PVE (within 48 hours)
  * Scan 3: Late after PVE (at 3-8 weeks).
* Scans 1 and 3: routine liver MR sequences with/without contrast (Gadoxetic acid, Eovist) and 4D phase contrast of the portal venous system. The 4D phase contrast sequence will be repeated twice at each time point, adding about 15-30 minutes to each scan.
* Scan 2: 4D phase contrast sequences and imaging for localization.

4D PC MRA is a new non-contrast MRA technique that can measure flow of blood within vessels of interest over time.

4Dimensional Phase Contrast Magnetic Resonance Angiography

Portal vein embolization

Nael E Saad, M.D.

The investigators hypothesize that 4Dimensional Phase Contrast Magnetic Resonance Angiography (4D PC MRA) evaluation of portal venous flow predicts underlying liver function and hypertrophic potential in patients with liver cancer presenting for portal vein embolization (PVE). 4D PC MRA may provide a non-invasive measure of liver function that could help determine which patients could safely and successfully undergo PVE and subsequent resection of tumor. By comparing 4D PC MRA results with invasive catheter measurements the investigators will validate the flow findings. Further regression/correlation analysis with functional measures of the liver (HIDA scans), volumetrics, Doppler flow analysis, histology, and outcomes will help the investigators to determine the ability of 4D PC MRA to predict functional status and hypertrophic potential of the liver prior to PVE and hepatectomy allowing for better patient selection and reduced morbidity/mortality.

4D Phase Contrast MR: Hypertrophy in Liver Cancer

4D Phase Contrast MR: Validation and Evaluation of Hypertrophy in Liver Cancer

-Data from the 4D PC MRA will be compared with the reference standards of the catheter-based flow quantification to validate venous flow findings

-Data from the 4D PC MRA will be compared with the reference standards of the Doppler Flow Analysis to measure flow velocities

-4D PC MRA results will be compared with invasive catheter measurements to validate the portal venous flow findings. Regression/correlation analysis will be used to analyze association between 4D PC MRA and liver function. Residuals will be tested for normality with the Shapiro-Wilk W test, and if residuals are non-normally distributed, the Spearman's rank correlation coefficient will be used

-Data from the 4D PC MRA will be compared with the reference standards of the HIDA scan and biopsy specimens.

-Data from the 4D PC MRA will be compared with the reference standards of the Doppler Flow Analysis to measure direction of flow

Washington University School of Medicine

Rare Diseases

Carcinoma, Hepatocellular

Biliary Tract Cancer

Patients will receive (a minimum of 3 patients) escalating doses of Salmonella typhimurium to achieve a maximum tolerated dose (MTD).

Attenuated Salmonella typhimurium (virulent strain x4550) will be given orally in escalating dose groups: Level 1 = 10\^5, Level 2 = 10\^6, Level 3 = 10\^7, Level 4 = 10\^8, Level 5 = 10\^9, Level 6 = 10\^10.

Salmonella typhimurium

Edward W. Greeno, MD

The working hypothesis is that oral administration of an attenuated strain of Salmonella typhimurium is safe and efficacious for patients with unresectable hepatic metastasis from a solid tumor cancer. The primary objective of the study is to determine the MTD of Salmonella typhimurium in the treatment.

This phase I study will be done to evaluate a dose escalation scheme of oral administration of an attenuated strain of Salmonella typhimurium expressing human interleukin-2 (IL-2) in patients with unresectable hepatic metastases from a solid tumor cancer. Standard Phase I dose escalation scheme will be used to determine the MTD of Salmonella Typhimurium. Six dose levels of Salmonella will be studied with a minimum of 3 patients enrolled in a dose level.

IL-2 Expressing, Attenuated Salmonella Typhimurium in Unresectable Hepatic Spread

A Phase 1 Study of an IL-2 Expressing, Attenuated Salmonella Typhimurium in Patients With Unresectable Hepatic Spread From Any Non-Hematologic Primary

Maximum tolerated dose will be determined by the number of patients with Dose limiting toxicity (DLT) at a given dose level. DLT is defined as treatment related: Sepsis (salmonella) syndrome, Grade 4 vomiting or diarrhea, Other grade 3 or greater toxicity. If \> or = 2 patients at a dose level has a DLT, this level will be declared the MTD.

Evaluation is performed using Response Evaluation Criteria in Solid Tumors (RECIST). Each patient will be assigned one of the following categories: Complete response (CR) the disappearance of all target lesion; Partial response (PR) at least a 30% decrease; Progressive disease (PD) at least a 20% increase, or the appearance of one or more new lesions; Stable disease (SD) neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease; early death from malignant disease; unknown (insufficient evaluation to determine response status).

Patients receiving doses of 10\^5 through 10\^10 Colony forming units of Salmonella typhimurium had their peripheral blood flow cytometry performed to identify the NK (Natural killer) cells population (CD8-, CD4-, CD49b+) prior to administration and at 5 weeks post administration.

The flow cytometry data below was gathered by gating on the lymphocyte population of cells in the patient's blood, as determined by FSC vs. SSC. The mean percentage of NK cells in sample's lymphocyte population is given.

Patients receiving doses of 10\^5 through 10\^10 Colony forming units of Salmonella typhimurium had their peripheral blood flow cytometry performed to identify the NK (Natural killer) cells population (CD25+, FoxP3+) prior to administration and at 5 weeks post administration.

The flow cytometry data below was gathered by gating on the lymphocyte population of cells in the patient's blood, as determined by FSC vs. SSC. The mean percentage of T cells in sample's lymphocyte population is given.

Masonic Cancer Center, University of Minnesota

Patients received Level 1 = 10\^5th dose of Salmonella typhimurium

Salmonella Typhimurium 10 to the 5 th - Level 1

Patients received Level 2 = 10\^6th dose of Salmonella typhimurium

Salmonella Typhimurium 10 to the 6 th - Level 2

Patients received Level 3 = 10\^7th dose of Salmonella typhimurium

Salmonella Typhimurium 10 to the 7 th - Level 3

Patients received Level 4 = 10\^8th dose of Salmonella typhimurium

Salmonella Typhimurium 10 to the 8 th - Level 4

Patients received Level 5 = 10\^9th dose of Salmonella typhimurium

Salmonella Typhimurium 10 to the 9 th - Level 5

Patients received Level 6 = 10\^10th dose of Salmonella typhimurium

Salmonella Typhimurium 10 to the 10 th - Level 6

Total

Age, Categorical

Race (NIH/OMB)

Daniel Saltzman

Salmonella Typhimurium 10 to the 9th - Level 5

Number of Participants With Dose Limiting Events to Determine the Maximum Tolerated Dose (MTD) of Salmonella Typhimurium

Number of Participants With Complete Response to Treatment

Before administration

After administration

Patients received Level 4 = 10\^8 th dose of Salmonella typhimurium

Patients received Level 1 = 10\^10 th dose of Salmonella typhimurium

One patient in 10 to the 6 th - Level 2 arm was not evaluable. One patient in 10 to the 7 th - Level 3 arm was not evaluable. Two patients in 10 to the 8 th - Level 4 arm were not evaluable. Two patients in 10 to the 9th - Level 5 arm were not evaluable. Two patients in 10 to the 10th - Level 6 arm were not evaluable.

Peripheral Blood NK Cells Count

Patients received Level 2 = 10\^6 th dose of Salmonella typhimurium

Patients received Level 3 = 10\^7 th dose of Salmonella typhimurium

Patients received Level 5 = 10\^10 th dose of Salmonella typhimurium

Patients received Level 6 = 10\^10 th dose of Salmonella typhimurium

Peripheral Blood T Cells Count

Patients received Level 1 = 10\^5 dose of of Salmonella typhimurium

Patients received Level 4 = 10\^7th dose of Salmonella typhimurium

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

AFP + GM-CSF Plasmid Prime and AFP Adenoviral Vector Boost

James Pingpank, MD

To evaluate the safety, toxicity and immunological effects of adjuvant administration of an experimental therapy consisting on priming with three intramuscular administrations of a plasmid expressing human AFP (phAFP) together with a plasmid expressing human GM-CSF (phGM-CSF), followed by a single intramuscular boost with an AFP adenoviral vector (AdVhAFP) to patients with locoregionally pre-treated hepatocellular carcinoma (HCC).

Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma

A Phase I/II Trial Testing Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma

National Cancer Institute (NCI)

Lisa H. Butterfield, Ph.D.

Professor of Medicine, Surgery and Immunology

Gallbladder Cancer

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Bilirubin

Starting dose of 500 mg/m2 (400 mg/m2 for patients with an elevated bilirubin at baseline) administered intravenously by a 1-hour infusion weekly for the first 5 weeks of a 6 week cycle.

Taxoprexin

Ahmed Kaseb, M.D.

To evaluate objective response rate and duration of response to weekly Taxoprexin®.

To evaluate the safety profile of weekly Taxoprexin® in this patient population.

To evaluate overall survival in the same patient population.

To evaluate time to disease progression, and the time to treatment failure in patients with primary liver cancer being treated with weekly Taxoprexin® Injection.

To explore the trough and peak blood levels of Taxoprexin® and paclitaxel in these patients.

This is a Phase II open-label study of weekly Taxoprexin® Injection in patients with advanced primary cancers of the liver, including hepatocellular carcinoma (HCC), or carcinoma of the gallbladder or biliary tract (BTC), who have not received prior systemic cytotoxic therapy for advanced disease. Patients may have previously received radiation and/or systemic chemotherapy as adjuvant therapy. Patients may not have been treated previously with a taxane. Patients may have been previously treated with up to two immunological and/or biologic agents (e.g., interferon, monoclonal antibodies, tyrosine kinase inhibitors). Patients will receive Taxoprexin® Injection at a dose of 500mg/m2 (400mg/m2 for patients with an elevated bilirubin at baseline) intravenously by 1-hour infusion weekly for the first five weeks of a six week cycle. Treatment will continue until progression of disease, intolerable toxicity, refusal of continued treatment by patient or Investigator decision.

Taxoprexin® Treatment for Advanced Primary Cancers of the Liver

Phase II Open-Label Study of Weekly Taxoprexin® (DHA-paclitaxel) Injection as Second Line Therapy for Patients With Advanced Primary Cancers of the Liver, Including Hepatocellular Carcinoma and Carcinoma of the Gallbladder or Biliary Tract

American Regent, Inc.

Patients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation.

Patients who meet the eligibility criteria will undergo microwave ablation (MWA) with the NEUWAVE Microwave Ablation System with or without Ablation Confirmation of at least one soft-tissue liver lesion, in accordance with the study site's standard-of-care (SOC) practices.

Jaclyn (Calia) Stanziola

Julie Peveto

Roger Tomihama, MD

Justin McWilliams, MD

Christopher Laing, MD

Thomas Le, MD

Beau Toskich, MD

Scott Perrin, MD

Constantinos T. Sofocleous

Kevin Anton, MD, PhD

Bruno Odisio, MD

Ziv Haskal, MD

Olivier Pellerin, MD. PhD.

Tarik Baetens, MD

Koert de Jong, MD

Too Chow Wei, MBBS, FRCR, MMed, FAMS

Pua Uei

This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.

This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System. The data gathered from participating sites will be available to be analyzed to develop ablation parameter guidance for ablation approaches under varying patient liver tissue conditions and liver lesions.

This is an "umbrella registry," which was included as an optional component in other NEUWAVE studies; hence, data from consenting patients who are or will be enrolled in other NEUWAVE soft tissue liver lesion ablation studies will be included in this registry. All other patients will be enrolled and followed prospectively, enrolled retrospectively with prospective, longitudinal follow up, or enrolled retrospectively with all retrospective follow up.

Enrollment for this study will include up to 1,500 patients throughout the world who underwent or are scheduled to undergo microwave ablation of one or more soft tissue liver lesions using the NEUWAVE Microwave Ablation System or the NEUWAVE Microwave Ablation System with Ablation Confirmation.

NOLA (NeuWave Observational Liver Ablation) Registry

A Multicenter Observational Registry to Develop Ablation Parameter Guidance for Microwave Liver Ablation of Soft Tissue Lesions

Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Technical success, defined as ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (i.e. the ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative margin), as assessed by CT, MRI, PET, US, and/or X-ray, immediately following the procedure.

Technique efficacy, ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (i.e., the ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative margin), as assessed by CT, MRI, PET, US, and/or X-ray, at Visit 3 (between 7 days and less than 3 months post-ablation).

Target lesion recurrence (local recurrence) rate is evaluated at every visit after ablation of the target lesion(s), and overall evaluation at the 5-year follow-up, as assessed by CT, MRI, PET, US, and/or X-ray.

Secondary efficacy rate, defined as the percentage of soft tissue lesions that have undergone successful repeat ablations (target or non-target) following identification of local soft tissue lesion progression, as assessed by CT, MRI, PET, US, and/or X-ray. A successful repeat ablation will be defined as ablation of the lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (i.e. the ablation zone completely overlaps or encompasses the lesion plus an ablative margin), as assessed by CT, MRI, PET, US, and/or X-ray, immediately following the procedure.

Regional recurrence rate at a separate location in the liver (outside the initial treatment site(s)), evaluated at every visit after ablation of the target lesion(s), and overall evaluation at the 5-year follow-up, as assessed by CT, MRI, PET, US, and/or X-ray.

Recurrence-free survival, evaluated at every visit after ablation of the target lesion(s), and overall evaluation at the 5-year follow-up, as assessed by CT, MRI, PET, US, and/or X-ray.

Overall survival, evaluated at every visit after ablation of the target lesion(s), and overall evaluation at the 5-year follow-up.

Incidence of adverse events (AEs) (SAEs) that are deemed at least unlikely related to the procedure or device and all serious adverse events (SAEs) from day of ablation through the end of the study.

European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and liver-specific QLQ-HCC18 are questionnaires that will be completed at the Ablation Visit (pre-ablation), and each study visit afterwards, up to 9-12 months post-ablation.

Note: These two questionnaires were chosen as tools to assess overall health status/quality of life in the patient population with soft-tissue liver lesions.

The Numeric Pain Rating Scale is a questionnaire where the patient reports their pain utilizing a 0-10 scale (where 0 is 'no pain' and 10 is 'maximum pain'). Patients will complete this questionnaire at the Ablation Visit (pre- and post-ablation), and at the first study visit after the ablation (7 days to 3 months post-ablation).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ablation Confirmation Study	NCT03753789	Cancer of the L... Liver Cancer Neoplasms, Live...	Microwave Ablat...	22 Years -	Ethicon, Inc.
4D Phase Contrast MR: Hypertrophy in Liver Cancer	NCT02618447	Liver Cancer Cancer of the L...	4Dimensional Ph... Portal vein emb...	18 Years -	Washington University School of Medicine
IL-2 Expressing, Attenuated Salmonella Typhimurium in Unresectable Hepatic Spread	NCT01099631	Cancer of the L... Liver Cancer Hepatoma Liver Neoplasms Biliary Cancer	Salmonella typh...	18 Years -	Masonic Cancer Center, University of Minnesota
Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma	NCT00669136	Hepatocellular ... Hepatoma Liver Cancer, A... Liver Cell Carc... Liver Cell Carc... Cancer of Liver Cancer of the L... Cancer, Hepatoc... Hepatic Cancer Hepatic Neoplas... Hepatocellular ... Liver Cancer Neoplasms, Hepa... Neoplasms, Live...	AFP + GM-CSF Pl...	18 Years - 80 Years	University of Pittsburgh
Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma	NCT00669136	Hepatocellular ... Hepatoma Liver Cancer, A... Liver Cell Carc... Liver Cell Carc... Cancer of Liver Cancer of the L... Cancer, Hepatoc... Hepatic Cancer Hepatic Neoplas... Hepatocellular ... Liver Cancer Neoplasms, Hepa... Neoplasms, Live...	AFP + GM-CSF Pl...	18 Years - 80 Years	University of Pittsburgh
Taxoprexin® Treatment for Advanced Primary Cancers of the Liver	NCT00422877	Cancer of the L...	Taxoprexin	18 Years -	American Regent, Inc.
NOLA (NeuWave Observational Liver Ablation) Registry	NCT04107766	Cancer of the L... Liver Cancer Neoplasms, Live...	Microwave Ablat...	22 Years -	Ethicon, Inc.
Ablation Confirmation Study	NCT03753789	Cancer of the L... Liver Cancer Neoplasms, Live...	Microwave Ablat...	22 Years -	Ethicon, Inc.

Spots Global Cancer Trial Database for cancer of the liver