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Study to Evaluate VORTX Rx (Theresa) (Theresa)

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ClinicalTrials.gov Identifier: NCT03741088
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
HistoSonics, Inc.

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

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Liver Metastases Device: VORTX Rx treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: 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 (Theresa Study)
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : July 21, 2019
Estimated Study Completion Date : September 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: VORTX Rx treatment
Focused ultrasound ablation of liver tumors.
Device: VORTX Rx treatment
Cavitation-based cellular destruction using focused ultrasound




Primary Outcome Measures :
  1. Acute technical performance of the VORTX Rx® medical device for the ablation of primary and metastatic liver tumors [ Time Frame: 1-day post ablation ]
    targeted tissue ablation will be evaluated using MRI analysis to assess acute technical success defined as the ability of the device to create an ablation zone per planned ablation volume (PAV)


Secondary Outcome Measures :
  1. Safety profile of the VORTX Rx. Incidence of Adverse events (serious and non-serious) that are probably or definitely device-related [ Time Frame: 2 months ]
    measured on all adverse events (serious and non-serious) that are device-related

  2. Local tumor progression [ Time Frame: 1 week, 1 month and 2 months post-procedure. ]
    The ablation zone will be assessed post-procedurally to evaluate local tumor progression by contrast-enhanced MRI imaging

  3. Involution of the ablation zone [ Time Frame: 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 1 week, 1 month and 2 months

  4. Assessment of liver panel. [ Time Frame: 1-day post ablation, 1 week and 1 and 2 months post procedure. ]
    Liver panel will be evaluated on the basis of the change of aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, albumin and bilirubin, gamma glutamyl transpeptidase (GGT), prothrombin time (PT) and international normalized ratio (INR) from baseline to evaluation visits 1 day, 1 week and 1 and 2 months post procedure.

  5. Immunologic assessment. [ Time Frame: 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+, C-reactive protein [CRP], complement C3, C4 and CH50, immunoglobulins [IgG, IgM, IgA], interleukin-6 [IL-6], carcinoembryonic antigen [CEA], 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.

  6. Assesment of quality of life by using patient questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer) [ Time Frame: 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.


  7. Pain assessment by VAS scale and analgesic requirements after the ablation procedure. [ Time Frame: 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.

    Evaluate analgesic treatment prescription in the 24-hour period post-procedure and during the one week period post-procedure.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741088


Contacts
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Contact: Marta Dominguez 0034 91 456 11 05 m.dominguez@dynasolutions.com

Locations
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Spain
Clinica Diagonal Recruiting
Esplugues De Llobregat, Barcelona, Spain, 08950
Contact: Joan Vidal-Jove    0034 932 05 32 13    jvidal@khuab.com   
Principal Investigator: Joan Vidal-Jove         
Hospital universitario Mutua Terrassa Recruiting
Terrassa, Barcelona, Spain, 08221
Contact: Joan Vidal-Jove    0034 937 36 50 50    jvidal@mutuaterrassa.es   
Principal Investigator: Joan Vidal-Jove         
Hospital Universitario Vall d´Hebrón Recruiting
Barcelona, Spain, 08035
Contact: Xavier Serres    0034 93 489 30 00    xavierserresc@gmail.com   
Principal Investigator: Xavier Serres         
Sponsors and Collaborators
HistoSonics, Inc.
Investigators
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Principal Investigator: Joan Vidal Jove, MD Mutua Terrassa , Barcelona, Spain

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Responsible Party: HistoSonics, Inc.
ClinicalTrials.gov Identifier: NCT03741088     History of Changes
Other Study ID Numbers: 03.CP.0.3
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases