Histotripsy with HistoSonics System for Liver Cancer

(#HOPE4LIVER US Trial)

Recruiting at 6 trial locations

Overseen By Christine Sullivan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HistoSonics, Inc.

Must not be taking: Bevacizumab, Chemotherapy, Immunotherapies, others

Disqualifiers: Pregnancy, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: ≤36 hours

47 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, if you are on investigational medications or certain cancer treatments like bevacizumab, chemotherapy, or immunotherapy, you may need to stop them for a specified period before the procedure.

How does the HistoSonics System treatment for liver cancer differ from other treatments?

The HistoSonics System uses histotripsy, a unique non-invasive treatment that destroys liver cancer tissue through mechanical means rather than heat, avoiding the limitations of thermal methods like the heat sink effect. This approach allows for precise targeting and preservation of surrounding healthy structures, offering a novel alternative to traditional thermal ablation techniques. ^{1 2 3 4 5}

Research Team

Timothy J Ziemlewicz, MD

Principal Investigator

University of Wisconsin, Madison

Clifford S Cho, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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.

Inclusion Criteria

My kidney function is normal, with creatinine levels less than twice the upper limit.

I meet the health requirements set within the last week.

I have been diagnosed with liver cancer or cancer that has spread to my liver.

Exclusion Criteria

Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol

I was treated with bevacizumab and stopped it less than 40 days ago.

Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive histotripsy treatment for liver tumors using the HistoSonics System

≤36 hours

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and efficacy, including imaging to assess technical success

30 days

1 visit (in-person)

Extended Follow-up

Participants are evaluated at 6 months and followed annually for up to five years post-index procedure

5 years

Treatment Details

Interventions

• HistoSonics System

Trial Overview 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.

Participant Groups

Group I: HistoSonics System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

HistoSonics, Inc.

Lead Sponsor

Trials

9

Recruited

5,200+

References

1. England pubmed.ncbi.nlm.nih.gov

Image-guided non-invasive ultrasound liver ablation using histotripsy: feasibility study in an in vivo porcine model. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of Histotripsy on Local Tumor Progression in an in vivo Orthotopic Rodent Liver Tumor Model. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Non-Invasive Ultrasound Liver Ablation Using Histotripsy: Chronic Study in an In Vivo Rodent Model. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A Multi-centre, Single Arm, Non-randomized, Prospective European Trial to Evaluate the Safety and Efficacy of the HistoSonics System in the Treatment of Primary and Metastatic Liver Cancers (#HOPE4LIVER). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

An X-Ray C-Arm Guided Automatic Targeting System for Histotripsy. [2023]