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Procedure

Histotripsy with HistoSonics System for Liver Cancer (#HOPE4LIVER US Trial)

N/A
Waitlist Available
Led By Timothy J Ziemlewicz, MD
Research Sponsored by HistoSonics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Renal function: serum creatinine <2x ULN
Subject is diagnosed with hepatocellular carcinoma (HCC) or liver metastases (mets) from other primary cancers
Must not have
Targeted tumor(s) treatment volume overlaps a non-targeted tumor visible via imaging
Subject has a history of, or suspected to have, bleeding disorders that are uncorrectable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ≤36 hours post-index procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a device that uses sound waves to break down liver tumors. It targets patients with liver tumors that may not respond to other treatments. The device works by creating bubbles in the tumor, which then burst and destroy the tumor cells.

Who is the study for?
This trial is for adults with primary liver cancer or liver metastases who haven't had success with other treatments. They must have good liver, kidney, and blood function, no more than three tumors each ≤3cm in size, and be fit enough for general anesthesia. Pregnant women or those on certain recent treatments are excluded.
What is being tested?
The HistoSonics System's safety and effectiveness in treating liver tumors using Histotripsy—a non-invasive technique—are being tested. Participants will undergo this single-arm treatment to see how well it works against their tumors.
What are the potential side effects?
Potential side effects of the HistoSonics Histotripsy may include pain at the treatment site, bruising, bleeding, inflammation around the treated area, and possible damage to nearby tissues or organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is normal, with creatinine levels less than twice the upper limit.
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I have been diagnosed with liver cancer or cancer that has spread to my liver.
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My tumor is 3 cm or smaller.
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I can safely be put under general anesthesia.
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My liver function is mild to moderately impaired.
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I can take care of myself and am up and about more than half of the day.
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I have up to 3 tumors eligible for histotripsy treatment.
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My liver, kidney, and blood tests are within required ranges.
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My liver tests are within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My treatment is targeting a tumor that overlaps with another tumor not being specifically targeted.
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I have a bleeding disorder that cannot be corrected.
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I stopped my immunotherapy at least 4 weeks ago and recovered from its side effects.
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I am scheduled for bevacizumab treatment before my 30-day follow-up.
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I still experience side effects from cancer treatment, excluding hair loss, tiredness, nausea, vomiting, and nerve pain.
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My tumor is located in a specific part of my liver.
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I am eligible for surgery to remove my cancer.
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My kidney function is low, with creatinine >2.0 or EGFR <30, but I may be on dialysis.
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I haven't had major surgery or significant injury in the last 2 weeks, or I've fully recovered from one.
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My blood does not clot properly and cannot be corrected.
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My cancer treatment targets areas near important digestive system parts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~≤36 hours post-index procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and ≤36 hours post-index procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy: Technical Success
Primary Safety: Procedure-Related Major Complications
Secondary study objectives
Procedure-Related Major Complications
Secondary Efficacy: Technique Efficacy
Secondary Safety: All Adverse Events
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: HistoSonics SystemExperimental Treatment1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for liver cancer include surgical resection, radiation therapy (such as proton beam irradiation and stereotactic body radiation therapy), and systemic therapies (like chemotherapy and immunotherapy). Histotripsy, a non-invasive focused ultrasound therapy, mechanically destroys targeted tissues through precise acoustic energy, offering a promising alternative by minimizing damage to surrounding healthy tissues. This is particularly significant for liver cancer patients as it potentially reduces treatment-related complications and preserves liver function, which is crucial given the liver's vital role in metabolism and detoxification.

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Who is running the clinical trial?

HistoSonics, Inc.Lead Sponsor
8 Previous Clinical Trials
5,198 Total Patients Enrolled
Timothy J Ziemlewicz, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
Clifford S Cho, MDPrincipal InvestigatorUniversity of Michigan

Media Library

Liver Cancer Research Study Groups: HistoSonics System
~10 spots leftby Nov 2025
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