The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER) (#HOPE4LIVER)

  • STATUS
    Recruiting
  • End date
    Jul 28, 2023
  • participants needed
    45
  • sponsor
    HistoSonics, Inc.
Updated on 28 October 2022
renal function
carcinoma
neutrophil count

Summary

This trial is a single arm, non-randomized prospective trial. The objective of this trial is to evaluate the efficacy and safety of the HistoSonics System for the treatment of primary or metastatic tumors located in the liver.

Description

This trial is a single arm, non-randomized prospective trial. Following histotripsy treatment of liver tumor(s), subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Subjects will then be followed for 30 days. Data through the 30-day time point will be used for a Regulatory Submission to the Notified Body. Additionally, subjects will be followed for one (1) year post-index procedure, with evaluations at the 6-month and 1-year time points to estimate the efficacy and safety profile of the HistoSonics System as part of post-market clinical follow-up.

Details
Condition Liver Tumor, HCC, Metastasis
Treatment HistoSonics Histotripsy
Clinical Study IdentifierNCT04573881
SponsorHistoSonics, Inc.
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is ≥18 years of age
Subject has signed the Ethics Committee (EC) or Institutional Review Board (IRB) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments
Subject is diagnosed with hepatocellular carcinoma (HCC) or liver metastases (mets) from other primary cancers
Subject is able to undergo general anesthesia
Subject has a Child-Pugh Score of A or B (up to B8)
Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening
Subject meets the following functional criteria, ≤7 days prior to the index-procedure
Liver function: Alanine transaminase (ALT) and Aspartate transaminase (AST) <2.5x upper limit of normal (ULN) and bilirubin <2.5x ULN, and
Renal function: serum creatinine <2x ULN, and
Hematologic function: neutrophil count >1.0 x 10^9/L and platelet >50 x 10^9/L
Subject has an International Normalized Ratio (INR) score of <2.0 , ≤7 days prior to
the index procedure
The tumor(s) selected for histotripsy treatment must be ≤3 cm in longest diameter
Subject has not responded to and/or has relapsed and/or is intolerant of other available therapies including locoregional therapies, chemotherapy, immunotherapy and targeted therapies
Subject has an adequate acoustic window to visualize targeted tumor(s) using ultrasound imaging
Subject has a maximum of three (3) tumors to be treated with histotripsy during the index procedure, regardless of how many tumors the subject has

Exclusion Criteria

Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period
Subject is enrolled in another investigational trial and/or is taking investigational medication or treated with an investigational device ≤30-days prior to index procedure
In the Investigator's opinion, the subject has co-morbid disease(s) or condition(s) that would cause undue risk and preclude safe use of the HistoSonics System
Subject has a serum creatinine >2.0 mg/dL or estimated glomerular filtration rate (EGFR) <30, unless on dialysis
Subject has not recovered to common terminology criteria for adverse events (CTCAE) grade 1 or better from any adverse effects (except alopecia) related to previous anti-cancer therapy
Subject has major surgical procedure or significant traumatic injury ≤2 weeks prior to the index procedure or not fully recovered from side effects/complications of such procedure or trauma
Subject has a planned cancer treatment (e.g. resection, chemotherapy, etc.) from the index-procedure date and prior to completion of the 30-day follow-up visit
Subject has a history of, or suspected to have, bleeding disorders that are uncorrectable
Subject has a coagulopathy that is uncorrectable
Subject has previous treatment with bevacizumab that has not been discontinued >40 days prior to the planned index-procedure date
Subject has planned bevacizumab treatment prior to completion of the 30-day follow-up visit
Subject has previous treatments with chemotherapy and/or radiotherapy that has not been discontinued ≥2 weeks prior to the planned index-procedure date or has not recovered from related toxicity
Subject has previous treatment with immunotherapies that has not been discontinued ≥4 weeks prior to the index-procedure or has not recovered from related toxicity
Subject has a life expectancy less than six (<6) months
In the opinion of the Investigator, histotripsy is not a treatment option for the subject
Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol
Subjects' tumor(s) is not treatable by the System's working ranges (refer to User Manual)
Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated
Targeted tumor(s) treatment volume overlaps a non-targeted tumor visible via imaging
The targeted tumor(s) is not clearly visible with diagnostic ultrasound and computed tomography (CT) or magnetic resonance (MR) imaging
Subjects' targeted tumor(s) has/have had prior locoregional therapy (e.g. ablation, embolization, radiation)
Subject is eligible for surgical resection
The targeted tumor(s) is located in liver segment 1
The Planned Treatment Volume intended to cover the targeted tumor includes or encompasses any portion of the main portal vein, common hepatic duct, common bile duct, gallbladder or stomach/bowel
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