Carcinoma, Hepatocellular, Liver Metastases
Conditions
Brief summary
Multi-center, Open-labeled, Non-randomized Study to Evaluate the Acute Technical Performance and Safety Profile of the VORTX Rx® for Ablation of Primary and Metastatic Liver Tumors
Detailed description
The study will assess the technical performance of the VORTX Rx device to deliver acoustic energy for cavitation-based cellular destruction. The planned duration of a single target tumor will be 60 minutes or less in a single session and adjusted intra-procedurally as necessary per investigator discretion. Subjects in this study must have an adequate acoustic window in the abdominal space in order to be eligible for enrollment. All patients who undergo ablation with the investigation device will be treated in a hospital environment under general anesthesia not to exceed four hours.
Interventions
DEVICEVORTX Rx treatment
Cavitation-based cellular destruction using focused ultrasound
Sponsors
HistoSonics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent before any study procedure is performed. * Subjects of both sexes aged 18 years or older. * Patients diagnosed with liver cancer, including HCC or liver metastases from breast, pancreas and/or colorectal cancers. If biopsy is required, there will be a minimum of 2-week period after biopsy and before the ablation. * HCC patients must meet the United Network for Organ Sharing and Organ Procurement and Transplantation Network (UNOS-OPTN) class 5 criteria for HCC (52). * Liver metastases patients must meet minimum criteria of liver biopsy and/or tissue diagnosis of primary tumor or metastatic tumor with new or growing liver tumors radiologically consistent with metastases. * Patients with liver cancer not candidates for surgical resection and/or not suitable for other locoregional treatments or patients who have not responded to or relapsed from conventional therapies. * Previous treatment with chemotherapy and/or radiotherapy is permitted provided that these treatments have been discontinued more than 2 weeks before the ablation and whenever patients have recovered from any related toxicity (53). * Previous treatment with immunotherapies is permitted provided that these therapies have been discontinued at least 4 weeks before the ablation and whenever patients have recovered from any related toxicity. * Previous ablation/surgery on other tumors different from those that will be targeted with the VORTX Rx® is allowed whenever a minimum of 2 weeks has elapsed since the prior procedure(s). * Tumor to be targeted for ablation will be clearly separated from other tumors or other critical areas (i.e. located in different segments of the liver) and located in segment 2, 3, 4, 5 or 6. * Largest diameter of targeted tumor ≤3 cm. * Tumor that will be targeted at a depth \<10 cm from the skin surface. * Must have an adequate acoustic window in the abdominal space to be able to visualize targeted tumor using ultrasound imaging; also must be able to visualize targeted tumor using MRI with optional CT imaging at investigator discretion. * Patients who can undergo general anesthesia. * Liver function score of Child-Pugh A or Child-Pugh B. * ECOG PS 0, 1 or 2 at screening. * Adequate liver function (ALT and AST \< 2.5 x upper limit of normal \[ULN\]), renal function (serum creatinine \<2 ULN and/or bilirubin \<2.5 UNL) and hematologic function (neutrophil count \> 1.0 x 109/L and platelet \> 50 x 109/L). * An INR \<2 within the last 7 days prior to the ablation in patients receiving anticoagulants, and an INR \<1.5 for patients not treated with anticoagulants. * Platelets level \>50 x 109/L within the last 7 days prior to the ablation.
Exclusion criteria
* Patients who decline or are unable to understand, provide or are unwilling to sign an informed consent form. * Pregnant or nursing (lactating) women; women of childbearing potential and sexually active that are unwilling to use adequate contraception (such as oral contraceptives, intrauterine contraceptive device or barrier method with spermicide or surgical sterilization). * Targeted tumor not clearly separated (i.e. located in the same liver segment as another tumor). * Targeted tumor located in liver segments 1, 7 or 8. * Targeted tumor \>3 cm. * Tumor that will be targeted \>10 cm from the skin surface. * Tumor not clearly visible with diagnostic ultrasound and MRI. * Liver function score of Child-Pugh C. * Liver volume reserve \<40% as measured by CT Scan (54). * Major surgical procedure, biopsy or significant traumatic injury \<2 weeks prior to the procedure or has not recovered from side effects/complications of such procedure or trauma. * Patient who has not recovered to grade 1 or better from any AEs (except alopecia, fatigue, nausea, vomiting) related to previous anti neoplastic therapies. * BMI \>30. * Parkinson's disease. * History of bleeding disorders (e.g. von Willebrand disease) or patients suspected to have a bleeding disorder. * Not able to temporarily discontinue warfarin, clopidogrel or any other long-acting anticoagulants at least two weeks before the procedure. * Initiation of any anticancer treatment during the screening period and during the follow-up study visits. * Life expectancy to be less than 6 months. * Unable or unwilling to complete all required screening and/or follow-up assessments. * Patients under ongoing treatment with an investigational medication or medical device that conflicts with the study device. * Patients for whom the investigator considers that the ablation is not in the patient's best interest. * Patients with active alcohol or drug addiction or any other condition that, in the investigator's opinion, would interfere with their ability to comply with the study requirements. * Patients with any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol. * Patients with known sensitivity to iodine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Technical Performance of the VORTX Rx® Medical Device for the Ablation of Primary and Metastatic Liver Tumors | 1-day post ablation | Number of Lesions that were Successfully Ablated according to technical success definition established in the protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Tumor Progression | 1 week, 1 month and 2 months post-procedure. | Number of patients who have indicated local tumor progression in at least one visit (1 week, 1 month, 2 months) for each tumor ablated. The ablation zone will be assessed post-procedurally to evaluate local tumor progression by contrast-enhanced MRI imaging |
| Involution of the Ablation Zone | 24hours, 1 week, 1 month and 2 months, post-procedure. | The involution of the ablation zone will be assessed post-procedurally by contrast-enhanced MRI imaging at 24h, 1 week, 1 month and 2 months |
| Assessment of Liver panel_Part 1 | Screening, 24 hours, 1 week, 1 month and 2 months. | Liver panel will be evaluated on the basis of the change of aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, gamma glutamyl transpeptidase (GGT) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure. |
| Assessment of Liver Panel_Part 2 | 24 hours, 1 week and 1 month and 2 months | Liver panel will be evaluated on the basis of the change of albumin from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure. |
| Assessment of Liver Panel_Part 3 | 24 hours, 1 week and 1month and 2 months | Liver panel will be evaluated on the basis of the change of bilirubin from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure |
| Assessment of Liver Panel_part 4 | 24 hours, 1 week and 1month and 2 months | Liver panel will be evaluated on the basis of the change of prothrombin time (PT) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure |
| Assessment of Liver Panel_Part 5 | 24 hours, 1 week and 1 month and 2 months | Liver panel will be evaluated on the basis of the change of International normalized ratio (INR = A system established by the World Health Organization (WHO) and the International Committee on Thrombosis and Hemostasis for reporting the results of blood coagulation (clotting) tests) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure. The INR is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Patient PT ÷ Control PT. Normal values for INR: 0.9-1.3. |
| Immunologic Assessment_Part 1 | Baseline/Screening, 1-day post ablation, 1 week and 1 and 2 months post procedure | Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests: CD3+, CD4+, CD8+, CD45+, CD16+, CD56+ and CD19+ from Baseline/Screening to 1-day post ablation, 1 week and 1 and 2 months post procedureprocedure. |
| Safety Profile of the VORTX Rx. Incidence of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-related | 2 months | Number of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-related |
| Immunologic Assessment_Part 3 | Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure. | Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests): complement C3 and C4, immunoglobulins \[IgG, IgM, IgA\] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure. |
| Immunologic Assessment_Part 4 | Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure. | Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests: complement CH50, alfa-fetoprotein \[AFP\], Cancer Antigens CA15-3 \[Breast Cancer\] and CA 19-9 \[Pancreatic Cancer\]) from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure. |
| Immunologic Assessment_Part 5 | Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure. | Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests): interleukin-6 \[IL-6\] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure. |
| Immunologic Assessment_Part 6 | Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure. | Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests): carcinoembryonic antigen \[CEA\] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure. |
| Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Screening, 1 and 2 months post procedure. | The EORTC QLQ-C30 is a 30-item generic health-related QoL instrument designed to assess cancer patients' physical, psychological and social functioning. It is composed of 9 multi-item scales (5 functional scales \[physical, role, cognitive, emotional, and social\], a global QoL scale \[GQoL\], and 3 symptom scales \[fatigue, pain, and nausea and vomiting\]), 5 single-item symptom scales assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea), and an item on the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0-100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. However, a high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Pain Assessment by VAS Scale | 1-day post ablation and 1 week post procedure. | Perform pain assessment by a 100 mm visual analog scale (VAS) where 0 is no pain and 100 is the maximum pain possible at 1-day and 1-week post-procedure. |
| Analgesic Requirements After the Ablation Procedure | in the 24-hour period post-procedure and during the one week period post-procedure | Evaluate analgesic treatment prescription in the 24-hour period post-procedure and during the one week period post-procedure. |
| Immunologic Assessment_Part 2 | Screening, 24 hours, 1 week and 1 and 2 months post procedure. | Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments: C-reactive protein \[CRP\], from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VORTX Rx Treatment Focused ultrasound ablation of liver tumors.
VORTX Rx treatment: Cavitation-based cellular destruction using focused ultrasound | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | VORTX Rx Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 63.1 years STANDARD_DEVIATION 13.6 |
| Body Mass Index (BMI) | 25.1 kg/m^2 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 0 | 2 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 1 | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment Spain | 8 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 3 Participants |
| Type of live tumors Hepatocellular carcinoma | 1 Participants |
| Type of live tumors Liver metastasis | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 7 / 8 |
| serious Total, serious adverse events | 2 / 8 |
Outcome results
Primary
Acute Technical Performance of the VORTX Rx® Medical Device for the Ablation of Primary and Metastatic Liver Tumors
Number of Lesions that were Successfully Ablated according to technical success definition established in the protocol.
Time frame: 1-day post ablation
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| VORTX Rx Treatment | Acute Technical Performance of the VORTX Rx® Medical Device for the Ablation of Primary and Metastatic Liver Tumors | 11 lesions |
Secondary
Analgesic Requirements After the Ablation Procedure
Evaluate analgesic treatment prescription in the 24-hour period post-procedure and during the one week period post-procedure.
Time frame: in the 24-hour period post-procedure and during the one week period post-procedure
Population: Number of patients with at least one drug due to Post-procedure pain (concomitant medication form).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VORTX Rx Treatment | Analgesic Requirements After the Ablation Procedure | At least one drug due to post-procedure pain: YES | 5 Participants |
| VORTX Rx Treatment | Analgesic Requirements After the Ablation Procedure | At least one drug due to post-procedure pain: NO | 3 Participants |
Secondary
Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
The EORTC QLQ-C30 is a 30-item generic health-related QoL instrument designed to assess cancer patients' physical, psychological and social functioning. It is composed of 9 multi-item scales (5 functional scales \[physical, role, cognitive, emotional, and social\], a global QoL scale \[GQoL\], and 3 symptom scales \[fatigue, pain, and nausea and vomiting\]), 5 single-item symptom scales assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea), and an item on the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0-100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. However, a high score for a symptom scale/item represents a high level of symptomatology/problems.
Time frame: Screening, 1 and 2 months post procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Global health status/QoL Screening | 70.8333 score on a scale | Standard Deviation 15.95712 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Global health status/QoL 1 month | 58.3333 score on a scale | Standard Deviation 28.05418 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Global health status/QoL 2 months | 70.8333 score on a scale | Standard Deviation 25 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Physical functioning Screening | 81.6667 score on a scale | Standard Deviation 12.6198 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Physical functioning 1 month | 83.3333 score on a scale | Standard Deviation 13.87777 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Physical functioning 2 months | 81.6667 score on a scale | Standard Deviation 18.35857 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Role functioning screening | 87.5000 score on a scale | Standard Deviation 15.95712 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Role functioning 1 month | 70.8333 score on a scale | Standard Deviation 28.46375 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Role functioning 2 months | 83.3333 score on a scale | Standard Deviation 13.60828 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Emotional functioning Screening | 87.5000 score on a scale | Standard Deviation 8.33333 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Emotional functioning 1 month | 87.5000 score on a scale | Standard Deviation 19.8373 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Emotional functioning 2 months | 83.3333 score on a scale | Standard Deviation 18.00206 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Cognitive functioning Screening | 79.1667 score on a scale | Standard Deviation 20.97176 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Cognitive functioning 1 month | 75.0000 score on a scale | Standard Deviation 21.51657 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Cognitive functioning 2 months | 79.1667 score on a scale | Standard Deviation 31.54949 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Social functioning Screening | 95.8333 score on a scale | Standard Deviation 8.33333 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Social functioning 1 month | 83.3333 score on a scale | Standard Deviation 13.60828 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Social functioning 2 months | 95.8333 score on a scale | Standard Deviation 8.33333 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Fatigue Screening | 30.5556 score on a scale | Standard Deviation 13.98117 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Fatigue 1 month | 41.6667 score on a scale | Standard Deviation 27.77778 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Fatigue 2 months | 25.0000 score on a scale | Standard Deviation 24.63729 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Nausea and vomiting Screening | 0 score on a scale | Standard Deviation 0 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Nausea and vomiting 1 month | 0 score on a scale | Standard Deviation 0 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Nausea and vomiting 1 months | 0 score on a scale | Standard Deviation 0 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Pain Screening | 16.6667 score on a scale | Standard Deviation 23.57023 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Pain 1 month | 20.8333 score on a scale | Standard Deviation 31.54949 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Pain 2 months | 41.6667 score on a scale | Standard Deviation 34.69443 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Dyspnea Screening | 0 score on a scale | Standard Deviation 0 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Dyspnea 1 month | 0 score on a scale | Standard Deviation 0 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Dyspnea 2 months | 0 score on a scale | Standard Deviation 0 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Insomnia Screening | 41.6667 score on a scale | Standard Deviation 41.94352 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Insomnia 1 month | 33.3333 score on a scale | Standard Deviation 47.14045 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Insomnia 2 months | 25.0000 score on a scale | Standard Deviation 31.91424 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Appetite loss Screening | 25.0000 score on a scale | Standard Deviation 50 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Appetite loss 1 month | 50.0000 score on a scale | Standard Deviation 43.03315 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Appetite loss 2 months | 8.3333 score on a scale | Standard Deviation 16.66667 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Constipation Screening | 8.3333 score on a scale | Standard Deviation 16.66667 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Constipation 1 month | 0 score on a scale | Standard Deviation 0 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Constipation 2 months | 0 score on a scale | Standard Deviation 0 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Diarrhea Screening | 33.3333 score on a scale | Standard Deviation 47.14045 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Diarrhea 1 month | 16.6667 score on a scale | Standard Deviation 19.24501 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Diarrhea 2 months | 16.6667 score on a scale | Standard Deviation 19.24501 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Financial difficulties Screening | 16.6667 score on a scale | Standard Deviation 19.24501 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Financial difficulties 1 month | 8.3333 score on a scale | Standard Deviation 16.66667 |
| VORTX Rx Treatment | Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) | Financial difficulties 2 months | 8.3333 score on a scale | Standard Deviation 16.66667 |
Secondary
Assessment of Liver panel_Part 1
Liver panel will be evaluated on the basis of the change of aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, gamma glutamyl transpeptidase (GGT) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure.
Time frame: Screening, 24 hours, 1 week, 1 month and 2 months.
Population: Only 4 patients have these parameters determined in all study points (screening, 24h, 1 day, 1 month and 2 months post-ablation)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | AST Screening | 60.7500 U/L | Standard Deviation 33.83662 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | AST 24 hours | 183.5000 U/L | Standard Deviation 80.71555 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | AST 1 week | 47.0000 U/L | Standard Deviation 25.17936 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | AST 1 month | 40.7500 U/L | Standard Deviation 10.68878 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | AST 2 months | 40.5000 U/L | Standard Deviation 19.94158 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | ALT Screening | 44.0000 U/L | Standard Deviation 22.13594 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | ALT 24 hours | 139.0000 U/L | Standard Deviation 56.12486 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | ALT 1 week | 58.5000 U/L | Standard Deviation 30.271 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | ALT 1 month | 27.5000 U/L | Standard Deviation 12.60952 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | ALT 2 months | 30.0000 U/L | Standard Deviation 15.55635 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | GGT Screening | 127.2500 U/L | Standard Deviation 105.05673 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | GGT 24 hours | 118.0000 U/L | Standard Deviation 111.48692 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | GGT 1 week | 159.7500 U/L | Standard Deviation 176.57364 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | GGT 1 month | 162.5000 U/L | Standard Deviation 139.50986 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | GGT 2 months | 102.5000 U/L | Standard Deviation 43.23964 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | Alkaline Phosphatase Screening | 156.5000 U/L | Standard Deviation 139.89639 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | Alkaline Phosphatase 24 hours | 127.2500 U/L | Standard Deviation 67.14847 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | Alkaline Phosphatase 1 week | 165.0000 U/L | Standard Deviation 88.67168 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | Alkaline Phosphatase 1 month | 146.7500 U/L | Standard Deviation 66.33941 |
| VORTX Rx Treatment | Assessment of Liver panel_Part 1 | Alkaline Phosphatase 2 months | 130.2500 U/L | Standard Deviation 74.44629 |
Secondary
Assessment of Liver Panel_Part 2
Liver panel will be evaluated on the basis of the change of albumin from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure.
Time frame: 24 hours, 1 week and 1 month and 2 months
Population: Only 4 patients have these parameters determined in all study points (screening, 24h, 1 day, 1 month and 2 months post-ablation)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VORTX Rx Treatment | Assessment of Liver Panel_Part 2 | Albumin Screening | 40.0250 g/L | Standard Deviation 2.88603 |
| VORTX Rx Treatment | Assessment of Liver Panel_Part 2 | Albumin 24 hours | 34.7500 g/L | Standard Deviation 1.13284 |
| VORTX Rx Treatment | Assessment of Liver Panel_Part 2 | Albumin 1 week | 37.5250 g/L | Standard Deviation 1.95683 |
| VORTX Rx Treatment | Assessment of Liver Panel_Part 2 | Albumin 1 month | 39.3750 g/L | Standard Deviation 0.63966 |
| VORTX Rx Treatment | Assessment of Liver Panel_Part 2 | Albumin 2 months | 40.1750 g/L | Standard Deviation 1.65806 |
Secondary
Assessment of Liver Panel_Part 3
Liver panel will be evaluated on the basis of the change of bilirubin from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure
Time frame: 24 hours, 1 week and 1month and 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VORTX Rx Treatment | Assessment of Liver Panel_Part 3 | Total Bilirrubin 1 month | 0.5250 mg/dL | Standard Deviation 0.11561 |
| VORTX Rx Treatment | Assessment of Liver Panel_Part 3 | Total Bilirrubin 2 months | 0.7050 mg/dL | Standard Deviation 0.31268 |
| VORTX Rx Treatment | Assessment of Liver Panel_Part 3 | Total Bilirrubin Screening | 0.7525 mg/dL | Standard Deviation 0.42578 |
| VORTX Rx Treatment | Assessment of Liver Panel_Part 3 | Total Bilirrubin 24 hours | 0.6425 mg/dL | Standard Deviation 0.20549 |
| VORTX Rx Treatment | Assessment of Liver Panel_Part 3 | Total Bilirrubin 1 week | 0.7600 mg/dL | Standard Deviation 0.32934 |
Secondary
Assessment of Liver Panel_part 4
Liver panel will be evaluated on the basis of the change of prothrombin time (PT) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure
Time frame: 24 hours, 1 week and 1month and 2 months
Population: Only 4 patients have these parameters determined in all study points (screening, 24h, 1 day, 1 month and 2 months post-ablation)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VORTX Rx Treatment | Assessment of Liver Panel_part 4 | Prothrombin time 1 week | 92.7500 percentage of activity | Standard Deviation 8.38153 |
| VORTX Rx Treatment | Assessment of Liver Panel_part 4 | Prothrombin time Screening | 95.2500 percentage of activity | Standard Deviation 5.5 |
| VORTX Rx Treatment | Assessment of Liver Panel_part 4 | Prothrombin time 24 hours | 92.5000 percentage of activity | Standard Deviation 9.94987 |
| VORTX Rx Treatment | Assessment of Liver Panel_part 4 | Prothrombin time 1 month | 98.7500 percentage of activity | Standard Deviation 2.5 |
| VORTX Rx Treatment | Assessment of Liver Panel_part 4 | Prothrombin time 2 months | 91.2500 percentage of activity | Standard Deviation 17.5 |
Secondary
Assessment of Liver Panel_Part 5
Liver panel will be evaluated on the basis of the change of International normalized ratio (INR = A system established by the World Health Organization (WHO) and the International Committee on Thrombosis and Hemostasis for reporting the results of blood coagulation (clotting) tests) from baseline to evaluation visits 24 hours, 1 week and 1 and 2 months post procedure. The INR is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Patient PT ÷ Control PT. Normal values for INR: 0.9-1.3.
Time frame: 24 hours, 1 week and 1 month and 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VORTX Rx Treatment | Assessment of Liver Panel_Part 5 | INR Screening | 1.0500 ratio | Standard Deviation 0.5774 |
| VORTX Rx Treatment | Assessment of Liver Panel_Part 5 | INR 24 hours | 1.0750 ratio | Standard Deviation 0.09574 |
| VORTX Rx Treatment | Assessment of Liver Panel_Part 5 | INR 1 week | 1.0500 ratio | Standard Deviation 0.05774 |
| VORTX Rx Treatment | Assessment of Liver Panel_Part 5 | INR 1 month | 1.0250 ratio | Standard Deviation 0.05 |
| VORTX Rx Treatment | Assessment of Liver Panel_Part 5 | INR 2 months | 1.0750 ratio | Standard Deviation 0.15 |
Secondary
Immunologic Assessment_Part 1
Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests: CD3+, CD4+, CD8+, CD45+, CD16+, CD56+ and CD19+ from Baseline/Screening to 1-day post ablation, 1 week and 1 and 2 months post procedureprocedure.
Time frame: Baseline/Screening, 1-day post ablation, 1 week and 1 and 2 months post procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD3+ (T cells) Screening | 801.7500 cells/uL | Standard Deviation 374.33708 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD3+ (T cells) 24 hours | 618.2500 cells/uL | Standard Deviation 365.48814 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD3+ (T cells) 1 week | 713.7500 cells/uL | Standard Deviation 234.09596 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD3+ (T cells) 1 month | 587.7500 cells/uL | Standard Deviation 253.11575 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD3+ (T cells) 2 months | 632.0000 cells/uL | Standard Deviation 150.53017 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD4+ (T helper cells) Screening | 469.2500 cells/uL | Standard Deviation 146.20619 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD4+ (T helper cells) 24 hours | 374.7500 cells/uL | Standard Deviation 128.99709 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD4+ (T helper cells) 1 week | 445.2500 cells/uL | Standard Deviation 121.94637 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD4+ (T helper cells) 1 month | 357.0000 cells/uL | Standard Deviation 159.3424 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD4+ (T helper cells) 2 months | 382.2500 cells/uL | Standard Deviation 77.2415 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD8+ (T suppressor/cytotoxic cells) Screening | 262.7500 cells/uL | Standard Deviation 223.82638 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD8+ (T suppressor/cytotoxic cells) 24 hours | 220.5000 cells/uL | Standard Deviation 204.31593 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD8+ (T suppressor/cytotoxic cells) 1 week | 230.5000 cells/uL | Standard Deviation 139.01679 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD8+ (T suppressor/cytotoxic cells) 1 month | 186.7500 cells/uL | Standard Deviation 136.19196 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD8+ (T suppressor/cytotoxic cells) 2 months | 177.2500 cells/uL | Standard Deviation 85.4766 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD45+ (leucocyte common antigen) Screening | 1054.1425 cells/uL | Standard Deviation 384.46746 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD45+ (leucocyte common antigen) 24 hours | 843.0350 cells/uL | Standard Deviation 349.94733 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD45+ (leucocyte common antigen) 1 week | 938.3700 cells/uL | Standard Deviation 251.60549 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD45+ (leucocyte common antigen) 1 month | 788.4275 cells/uL | Standard Deviation 257.71702 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD45+ (leucocyte common antigen) 2 months | 831.2675 cells/uL | Standard Deviation 194.76464 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD16+ Screening | 134.3000 cells/uL | Standard Deviation 69.78811 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD16+ 24 hours | 78.4750 cells/uL | Standard Deviation 50.40353 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD16+ 1 week | 116.1750 cells/uL | Standard Deviation 65.7246 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD16+ 1 month | 109.7500 cells/uL | Standard Deviation 53.1123 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD16+ 2 months | 100.5000 cells/uL | Standard Deviation 47.59202 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD56+ (NKT cells) Screening | 85.4500 cells/uL | Standard Deviation 85.14507 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD56+ (NKT cells) 24 hours | 56.5000 cells/uL | Standard Deviation 61.00213 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD56+ (NKT cells) 1 week | 73.9500 cells/uL | Standard Deviation 69.58934 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD56+ (NKT cells) 1 month | 63.2500 cells/uL | Standard Deviation 68.07533 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD56+ (NKT cells) 2 months | 60.7500 cells/uL | Standard Deviation 50.129 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD19+ (B-lymphocyte antigen) Screening | 85.0000 cells/uL | Standard Deviation 58.66856 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD19+ (B-lymphocyte antigen) 24 hours | 83.5000 cells/uL | Standard Deviation 58.31238 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD19+ (B-lymphocyte antigen) 1 week | 86.5000 cells/uL | Standard Deviation 53.10053 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD19+ (B-lymphocyte antigen) 1 month | 70.0000 cells/uL | Standard Deviation 50.51732 |
| VORTX Rx Treatment | Immunologic Assessment_Part 1 | CD19+ (B-lymphocyte antigen) 2 months | 87.0000 cells/uL | Standard Deviation 51.71718 |
Secondary
Immunologic Assessment_Part 2
Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments: C-reactive protein \[CRP\], from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.
Time frame: Screening, 24 hours, 1 week and 1 and 2 months post procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VORTX Rx Treatment | Immunologic Assessment_Part 2 | C reactive protein Screening | 5.9750 mg/L | Standard Deviation 5.67355 |
| VORTX Rx Treatment | Immunologic Assessment_Part 2 | C reactive protein 24 hours | 6.0250 mg/L | Standard Deviation 7.06323 |
| VORTX Rx Treatment | Immunologic Assessment_Part 2 | C reactive protein 1 week | 30.8250 mg/L | Standard Deviation 53.05735 |
| VORTX Rx Treatment | Immunologic Assessment_Part 2 | C reactive protein 1 month | 4.7750 mg/L | Standard Deviation 3.57713 |
| VORTX Rx Treatment | Immunologic Assessment_Part 2 | C reactive protein 2 months | 11.9500 mg/L | Standard Deviation 8.85795 |
Secondary
Immunologic Assessment_Part 3
Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests): complement C3 and C4, immunoglobulins \[IgG, IgM, IgA\] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.
Time frame: Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | Complement C3 Screening | 144.0000 mg/dL | Standard Deviation 53.61592 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | Complement C3 24 hours | 123.2000 mg/dL | Standard Deviation 25.76354 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | Complement C3 1 week | 150.5000 mg/dL | Standard Deviation 22.75229 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | Complement C3 1 month | 143.9000 mg/dL | Standard Deviation 44.60239 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | Complement C3 2 months | 134.7500 mg/dL | Standard Deviation 26.88711 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | Complement C4 Screening | 30.7750 mg/dL | Standard Deviation 20.29949 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | Complement C4 24 hours | 23.7750 mg/dL | Standard Deviation 6.58401 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | Complement C4 1 week | 29.8250 mg/dL | Standard Deviation 9.00717 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | Complement C4 1 month | 26.9500 mg/dL | Standard Deviation 11.01348 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | Complement C4 2 months | 28.0750 mg/dL | Standard Deviation 14.47236 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgG Screening | 867.2500 mg/dL | Standard Deviation 326.38359 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgG 24 hours | 792.9000 mg/dL | Standard Deviation 354.83048 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgG 1 week | 856.0000 mg/dL | Standard Deviation 335.2243 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgG 1 month | 916.7500 mg/dL | Standard Deviation 338.63784 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgG 2 months | 899.0000 mg/dL | Standard Deviation 334.19655 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgM Screening | 132.6250 mg/dL | Standard Deviation 59.75139 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgM 24 hours | 120.9000 mg/dL | Standard Deviation 51.44745 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgM 1 week | 132.3500 mg/dL | Standard Deviation 45.62846 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgM 1 month | 140.7500 mg/dL | Standard Deviation 43.69115 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgM 2 months | 141.2500 mg/dL | Standard Deviation 52.94075 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgA Screening | 147.5000 mg/dL | Standard Deviation 133.49871 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgA 24 hours | 130.0000 mg/dL | Standard Deviation 119.05766 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgA 1 week | 142.8000 mg/dL | Standard Deviation 131.15955 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgA 1 month | 145.9500 mg/dL | Standard Deviation 116.1153 |
| VORTX Rx Treatment | Immunologic Assessment_Part 3 | IgA 2 months | 129.3750 mg/dL | Standard Deviation 84.51147 |
Secondary
Immunologic Assessment_Part 4
Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests: complement CH50, alfa-fetoprotein \[AFP\], Cancer Antigens CA15-3 \[Breast Cancer\] and CA 19-9 \[Pancreatic Cancer\]) from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.
Time frame: Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | Complement CH50 Screening | 72.7500 U/ml | Standard Deviation 26.87471 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | Complement CH50 24 hours | 61.5000 U/ml | Standard Deviation 37.59876 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | Complement CH50 1 week | 61.0000 U/ml | Standard Deviation 34.0294 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | Complement CH50 1 month | 52.2500 U/ml | Standard Deviation 24.18505 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | Complement CH50 2 months | 60.2500 U/ml | Standard Deviation 36.59121 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | AFP Screening | 544.8050 U/ml | Standard Deviation 1084.79682 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | AFP 24 hours | 417.8550 U/ml | Standard Deviation 831.43014 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | AFP 1 week | 502.2350 U/ml | Standard Deviation 999.84372 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | AFP 1 month | 264.1675 U/ml | Standard Deviation 523.22173 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | AFP 2 months | 224.5900 U/ml | Standard Deviation 441.61247 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | CA 15-3 (breast cancer) Screening | 15.8500 U/ml | Standard Deviation 9.0294 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | CA 15-3 (breast cancer) 24 hours | 14.0000 U/ml | Standard Deviation 6.66433 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | CA 15-3 (breast cancer) 1 week | 14.3750 U/ml | Standard Deviation 7.20804 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | CA 15-3 (breast cancer) 1 month | 16.2250 U/ml | Standard Deviation 9.31786 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | CA 15-3 (breast cancer) 2months | 15.4250 U/ml | Standard Deviation 7.08396 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | CA 19-9 (pancreatic cancer) Screening | 167.8175 U/ml | Standard Deviation 300.24702 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | CA 19-9 (pancreatic cancer) 24 hours | 174.8450 U/ml | Standard Deviation 312.8671 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | CA 19-9 (pancreatic cancer) 1 week | 169.1675 U/ml | Standard Deviation 290.56204 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | CA 19-9 (pancreatic cancer) 1 month | 168.1200 U/ml | Standard Deviation 285.77017 |
| VORTX Rx Treatment | Immunologic Assessment_Part 4 | CA 19-9 (pancreatic cancer) 2 months | 256.9525 U/ml | Standard Deviation 475.14915 |
Secondary
Immunologic Assessment_Part 5
Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests): interleukin-6 \[IL-6\] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.
Time frame: Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VORTX Rx Treatment | Immunologic Assessment_Part 5 | Interleukin-6 Screening | 4.2225 pg/dl | Standard Deviation 2.88648 |
| VORTX Rx Treatment | Immunologic Assessment_Part 5 | Interleukin-6 24 hours | 3.4575 pg/dl | Standard Deviation 1.97481 |
| VORTX Rx Treatment | Immunologic Assessment_Part 5 | Interleukin-6 1 week | 14.7850 pg/dl | Standard Deviation 14.05719 |
| VORTX Rx Treatment | Immunologic Assessment_Part 5 | Interleukin-6 1 month | 3.8750 pg/dl | Standard Deviation 2.37905 |
| VORTX Rx Treatment | Immunologic Assessment_Part 5 | Interleukin-6 2 months | 5.8125 pg/dl | Standard Deviation 2.84372 |
Secondary
Immunologic Assessment_Part 6
Immunological response of ablation will be evaluated on the basis of immune tests conducted and tumor biomarker assessments (including, but not limited to, immune tests): carcinoembryonic antigen \[CEA\] from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.
Time frame: Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VORTX Rx Treatment | Immunologic Assessment_Part 6 | CEA Screening | 46.9300 ng/ml | Standard Deviation 50.75086 |
| VORTX Rx Treatment | Immunologic Assessment_Part 6 | CEA 24 hours | 50.4200 ng/ml | Standard Deviation 55.1653 |
| VORTX Rx Treatment | Immunologic Assessment_Part 6 | CEA 1 week | 37.7925 ng/ml | Standard Deviation 45.10227 |
| VORTX Rx Treatment | Immunologic Assessment_Part 6 | CEA 1 month | 44.6150 ng/ml | Standard Deviation 64.11322 |
| VORTX Rx Treatment | Immunologic Assessment_Part 6 | CEA 2 months | 54.0225 ng/ml | Standard Deviation 97.45371 |
Secondary
Involution of the Ablation Zone
The involution of the ablation zone will be assessed post-procedurally by contrast-enhanced MRI imaging at 24h, 1 week, 1 month and 2 months
Time frame: 24hours, 1 week, 1 month and 2 months, post-procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VORTX Rx Treatment | Involution of the Ablation Zone | Ablation zone volume (cm3): 24 hours | 10.5500 cubic centimeters | Standard Deviation 6.34405 |
| VORTX Rx Treatment | Involution of the Ablation Zone | Ablation zone volume (cm3): 1 week | 8.5000 cubic centimeters | Standard Deviation 9.56682 |
| VORTX Rx Treatment | Involution of the Ablation Zone | Ablation zone volume (cm3): 1 month | 5.9383 cubic centimeters | Standard Deviation 10.02174 |
| VORTX Rx Treatment | Involution of the Ablation Zone | Ablation zone volume (cm3): 2 months | 4.7683 cubic centimeters | Standard Deviation 9.47795 |
Secondary
Local Tumor Progression
Number of patients who have indicated local tumor progression in at least one visit (1 week, 1 month, 2 months) for each tumor ablated. The ablation zone will be assessed post-procedurally to evaluate local tumor progression by contrast-enhanced MRI imaging
Time frame: 1 week, 1 month and 2 months post-procedure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VORTX Rx Treatment | Local Tumor Progression | Progression: YES | 2 Participants |
| VORTX Rx Treatment | Local Tumor Progression | Progression: NO | 5 Participants |
| VORTX Rx Treatment | Local Tumor Progression | Progression: No data | 1 Participants |
Secondary
Pain Assessment by VAS Scale
Perform pain assessment by a 100 mm visual analog scale (VAS) where 0 is no pain and 100 is the maximum pain possible at 1-day and 1-week post-procedure.
Time frame: 1-day post ablation and 1 week post procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VORTX Rx Treatment | Pain Assessment by VAS Scale | VAS score: 24 hours | 4.3 score on a scale | Standard Deviation 7.9 |
| VORTX Rx Treatment | Pain Assessment by VAS Scale | VAS score: 1 week | 25.0 score on a scale | Standard Deviation 18.9 |
Secondary
Safety Profile of the VORTX Rx. Incidence of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-related
Number of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-related
Time frame: 2 months
Population: Although only 5 participants performed all protocol visits, adverse events from all patients were reported and analyzed.~Any of the 55 AEs reported was device-related.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VORTX Rx Treatment | Safety Profile of the VORTX Rx. Incidence of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-related | 0 Adverse Events |