The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy

Running, not enrolling · Not applicable

Conditions studied: Liver Neoplasms, Hepatocellular Carcinoma, Liver Metastases

In brief

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. The co-primary safety and efficacy endpoints must be met for the trial to be successful.

Key facts

Study ID: NCT04572633
Run by: HistoSonics, Inc.
People needed: 47
Starts: 2021-01-27
Expected to finish: 2027-09-01
Last updated by the study team: 2025-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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/or bilirubin <2.5 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
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
The tumor(s) selected for histotripsy treatment must be ≤3 cm in longest diameter
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.

You may not qualify if…

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 and/or has been treated with an investigational device ≤30-days prior to planned index procedure date
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 major surgical procedure or significant traumatic injury ≤2 weeks prior to the planned index procedure or not fully recovered (CTCAE grade 1 or better) from side effects/complications of such procedure or trauma
Subject has not recovered to common terminology criteria for adverse events (CTCAE) grade 1 or better from any adverse effects (except alopecia, fatigue, nausea, vomiting and peripheral neuropathy) related to previous anti-cancer therapy
Subject has a history of, or suspected to have, bleeding disorders that are uncorrectable
Subject has coagulopathy that is uncorrectable
Subject has a planned cancer treatment (e.g. resection, chemotherapy, etc.) after the planned index-procedure date and prior to completion of the 30-day follow-up visit
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 and has not recovered (CTCAE grade 1 or better) from related toxicity (except alopecia and peripheral neuropathy)
Subject has previous treatment with immunotherapies that has not been discontinued ≥4 weeks prior to the index-procedure and has not recovered from related toxicity (CTCAE grade 1 or better)
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
Subjects' target tumor(s) has/have had prior locoregional therapy (e.g. ablation, embolization, radiation)
Subject is eligible for surgical resection
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
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.

Where it is running

Miami Cancer Institute — Miami, Florida, United States
Tampa General Hospital — Tampa, Florida, United States
University of Chicago — Chicago, Illinois, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
University of Michigan Hospital — Ann Arbor, Michigan, United States
University Hospital - UW Health — Madison, Wisconsin, United States
Medical College of Wisconsin/Froedtert Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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