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Histotripsy (HistoSonics®) for Liver Tumours

Histotripsy (HistoSonics®) for Liver Tumours: a Phase II Safety and Efficacy Study

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06579833
Enrollment
60
Registered
2024-08-30
Start date
2024-08-29
Completion date
2028-09-01
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Tumour

Keywords

liver tumour

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.

Interventions

RADIATIONHistotripsy

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.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in tumour featuresup to 36 monthsChanges in tumour size and volume before and after intervention
Post procedure adverse events and complicationThe whole duration of hospital stay, normally 3 days on averagePost procedure adverse events and complication

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026