Histotripsy (HistoSonics®) for Liver Tumours

NCT06579833 | Active Not Recruiting

• 1 other identifier: UW24-442
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures. It works by using high-intensity ultrasound waves to create microscopic bubbles within the tumour tissue. These bubbles rapidly expand and collapse, generating shock waves that disrupt the tissue. The technique is highly precise and can be targeted to specific areas of the liver, allowing for selective destruction of tumour cells while minimizing damage to healthy tissue. This study will enrol 20 patients with liver tumours (be it primary or secondary liver tumours), monitor their post-operative adverse events, and study the changes in tumour size and volume after treatment. Histotripsy will be performed under general anaesthesia, with real-time monitoring by ultrasound, and deliver high-intensity ultrasound waves in single session or multiple sessions. Similar to other minimal invasive treatments, patients will be admitted 1 day prior, then receive Histotripsy on the next day and stay overnight for observation. Patients will be discharged on the 3rd day if unremarkable. During the hospital stay, blood samplings will be taken for evaluation around 2-4 times in total depending on the length of hospital stay.

Conditions

Liver Tumour

Keywords

liver tumour

Outcome Measures

Primary Outcomes (2)

• Changes in tumour features

  Changes in tumour size and volume before and after intervention

  up to 36 months

• Post procedure adverse events and complication

  Post procedure adverse events and complication

  The whole duration of hospital stay, normally 3 days on average

Study Arms (1)

Histotripsy

OTHER

Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures

Radiation: Histotripsy

Interventions

Histotripsy RADIATION

Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures. It works by using high-intensity ultrasound waves to create microscopic bubbles within the tumour tissue. These bubbles rapidly expand and collapse, generating shock waves that disrupt the tissue. The technique is highly precise and can be targeted to specific areas of the liver, allowing for selective destruction of tumour cells while minimizing damage to healthy tissue.

Also known as: HistoSonics

Histotripsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fit for general anaesthesia
• Liver tumour size \< 10cm
• Solitary or multifocal
• Primary liver tumour such as hepatocellular carcinoma or intrahepatic cholangiocarcinoma
• Secondary liver tumour such as liver metastasis
• Patients with operable or inoperable liver tumours
• Liver transplant candidates awaiting for liver graft

You may not qualify if:

• Refusal to take part in clinical trial
• Child C liver cirrhosis
• Not fit for general anaesthesia

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Albert Chan, MS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 30, 2024
• Study Start: August 29, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)