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Gastrointestinal Neoplasms

Digestive System Neoplasms

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Liver Diseases

Central Nervous System Depressants

All Drugs and Chemicals

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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

Adenocarcinoma

Carcinoma, Hepatocellular

Vaccines

The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.

cancer stem cell vaccine

Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors into immunosuppressed mice, preventing an assessment on the immunologic interactions and effects of CSCs. In this study, the investigators examined the vaccination effects produced by CSC-enriched populations from histologically distinct murine tumors after their inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic and more effective as an antigen source than unselected tumor cells in inducing protective antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed antibodies and T cells were capable of selective targeting CSCs and conferring anti-tumor immunity.

To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the investigators will harvest peripheral blood and tumor specimen from patients with hepatocellular cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the hepatocellular cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow tumor cells from the tumor specimen of the hepatocellular cancer patient using a similar protocol as investigators reported .

Aim 1: To demonstrate, in vitro, the relative cellular anti-hepatocellular cancer CSC immunity induced by hepatocellular cancer CSC-DC primed cytotoxic T cells.

Aim 2: To determine, in vitro, specific binding and lysis of hepatocellular cancer CSCs by antibodies produced by purified B cells from PBMCs stimulated with hepatocellular cancer CSC-DC.

Cancer Stem Cells Vaccine Therapy in Treating Hepatocellular Cancer Patients

Study of Cancer Stem Cell Vcccinie That as a Specific Antigen in Metastatic Adenocarcinoma of the Liver

University of Michigan

Fuda Cancer Hospital, Guangzhou

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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

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).

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Jie Yu, Doctor

Chaonan Chen

Qianqian Zeng

Ping Liang, Doctor

It has well accepted that tumor angiogenesis present aberrant vascular architecture and functional abnormalities, which is associated with tumorigenesis, tumor propagation and progression. By locating, separating and tracking microbubbles, the recently introduced and upgraded Ultrasound Localization Microscopy (ULM) surpassed classical wave diffraction limit. However, the acquisition of structural and functional parameters of microcirculation in vivo for ULM is still confined by the compromise between the resolution and penetration depth. The relatively long acquisition time induced the difficulty of motion correction potentially, which hampers the preclinical to clinical application in organs with distinct tissue motion such as the liver. Therefore, we take the lead in studying human liver lesion microvasculature, which remains a challenge for noninvasive, quantitative and functional intravital imaging especially due to its deep-seated location and strong motion. We developed a Super-resolution Ultrasound (SR-US) imaging technique based on ULM to assess its feasibility of visualizing and quantifying microvasculature in human organs.

In this study, 7 indexes were obtained by ultrasonic acquisition. These 7 indicators are used to describe and evaluate the microvessels in the tumor, so as to achieve the early identification and diagnosis of the tumor, and to monitor the growth of the tumor for a long time and evaluate the treatment of the tumor. This is not available with other ultrasound devices.

Based on contrast-enhanced ultrasound, this technology can provide information of smaller blood vessels, which will certainly contribute to the early diagnosis and real-time evaluation of solid tumors during treatment, and play an important role in clinical application.

Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid Tumors

The reason we cannot provide individual participant data (IPD) is because the data we obtained from the super-resolution ultrasound images is not publicly available

The product of the average speed of microbubbles in region of interest (ROI) and the ROI area

To describe the diameters of the tiniest blood vessels that can be explored

To describe the ratio of the number of blood vessels in the tumor to the cross-sectional area of the tumor

The ratio of blood vessel density between the core and peripheral areas of the tumor

The average velocity in the region of interest

The ratio of the total length of the curve path to the straight line distance from the beginning to the end of the curve

Perfusion ratio of tumor core to peripheral area

Chinese PLA General Hospital

Chief physician

Infections

Rare Diseases

Virus Diseases

Vaccinia

Communicable Diseases

Poxviridae Infections

DNA Virus Infections

Primary Liver Cancer

1e8 pfu (plaque forming units)total dose each treatment day

3e8 pfu (plaque forming units) total dose each treatment day

1e9 pfu (plaque forming units) total dose each treatment day

3e9 pfu (plaque forming units) total dose each treatment day

The total dose is divided between 1-3 tumors located within the liver. Patients are treated with JX-594 once every 3 weeks until progression at the site(s) of injection or until the patient has received a maximum of 4 treatments.

JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)

David Kirn, MD

The primary purpose of this study is to determine the maximum tolerable dose (MTD) and/or the maximum feasible dose (MFD), as well as to evaluate the safety of JX-594 (Pexa-Vec) injected within hepatic carcinoma tumors.

Patients are treated with JX-594 once every three weeks until progression at the site(s) of injection or until the patient has received a maximum of 4 treatments; four additional cycles can be administered to patients with an objective response of the injected tumor(s) (i.e. 8 total treatments possible). Study dose levels are 1e8 pfu, 3e8 pfu, 1e9 pfu and 3e9 pfu per treatment. Standard Phase I dose-escalation guidelines are used, with 2-6 patients enrolled per cohort (3 if no dose-limiting toxicities are reported).

A Study of Recombinant Vaccinia Virus to Evaluate the Safety and Efficacy of a Transdermal Injection Within the Tumor of Patients With Primary or Metastatic Hepatic Carcinoma

Phase 1 Clinical Study for Evaluating the Safety and Efficacy of a Transdermal Injection of JX-594 (Thymidine Kinase (-)/GM-CSF(+) Vaccinia Virus) Within the Tumor of Patients With Hepatic Carcinoma

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.
Cancer Stem Cells Vaccine Therapy in Treating Hepatocellular Cancer Patients	NCT02089919	Neoplasms, Live...	cancer stem cel...	18 Years - 75 Years	Fuda Cancer Hospital, Guangzhou
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
NOLA (NeuWave Observational Liver Ablation) Registry	NCT04107766	Cancer of the L... Liver Cancer Neoplasms, Live...	Microwave Ablat...	22 Years -	Ethicon, Inc.
Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid Tumors	NCT06018142	Neoplasms, Live... Neoplasms Malig... Neoplasm Metast... Ultrasound Microvessels		18 Years - 80 Years	Chinese PLA General Hospital
A Study of Recombinant Vaccinia Virus to Evaluate the Safety and Efficacy of a Transdermal Injection Within the Tumor of Patients With Primary or Metastatic Hepatic Carcinoma	NCT00629759	Neoplasms, Live...	JX-594: Recombi...	18 Years -	Jennerex Biotherapeutics
Ablation Confirmation Study	NCT03753789	Cancer of the L... Liver Cancer Neoplasms, Live...	Microwave Ablat...	22 Years -	Ethicon, Inc.

Spots Global Cancer Trial Database for neoplasms, liver