To hear about similar clinical trials, please enter your email below
Trial Title:
Histotripsy (HistoSonics®) for Liver Tumours
NCT ID:
NCT06579833
Condition:
Liver Tumour
Conditions: Official terms:
Liver Neoplasms
Conditions: Keywords:
liver tumour
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Histotripsy
Description:
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.
Arm group label:
Histotripsy
Other name:
HistoSonics
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Hong Kong
Address:
City:
Hong Kong
Zip:
0000
Country:
Hong Kong
Contact:
Last name:
Albert Chan, MS
Phone:
+85222553025
Email:
acchan@hku.hk
Investigator:
Last name:
Albert Chan, MS
Email:
Principal Investigator
Investigator:
Last name:
Vince Lau, MBBS
Email:
Sub-Investigator
Investigator:
Last name:
Kyongtae Bae, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Chi Leung Chiang, MBChB
Email:
Sub-Investigator
Investigator:
Last name:
Rina Hui, MBBS
Email:
Sub-Investigator
Start date:
September 2, 2024
Completion date:
September 1, 2028
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Source:
The University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06579833
