Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT07180706
Eligibility Criteria:
Inclusion Criteria:
* Ages Eligible for Study: 18 Years and older
* Diagnosed with a malignant liver tumor at National Taiwan University Hospital. - participants with intra-abdominal tumors measuring between 3 to 10 cm in diameter, such as hepatobiliary or pancreatic cancer, benign or malignant retroperitoneal tumors, or malignant sarcomas, who are experiencing tumor-related symptoms and discomfort.
* unresectable areas due to the presence of distant metastases, invasion of blood vessels or vital organs, or the risk of organ dysfunction resulting from tumor resection.
* participants with good physical condition, having an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, and an American Society of Anesthesiologists (ASA) score of less than 3.
* No severe hepatic or renal dysfunction (Child-Pugh class A/B); total serum bilirubin ≤ 5 mg/dL; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within five times the upper limit of normal; serum creatinine within two times the upper limit of normal.
* Normal coagulation function, with a prothrombin time international normalized ratio (PT-INR) ≤ 2.0 and a platelet count above 100,000.
* Estimated life expectancy of more than three months.
* The maximum depth from the tumor to the skin surface is within 14 cm.
Exclusion Criteria:
* Tumors that cannot be clearly localized by ultrasound.
* Inability to find a safe internal path for ultrasound to reach the tumor during imaging evaluation, such as the presence of unsuitable media for ultrasound propagation like skin scars, intestinal gas, calcified tumors, and bones in the path.
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Received treatment with an investigational agent/ procedure within 30 days prior to Histotripsy treatment
* Have undergone radiation therapy in the focused ultrasound treatment area within 30 days before or after treatment.
* arterial calcification in the ultrasound treatment area.
* Investigator-assessed contraindications
* Inability to undergo CT/MRI imaging
* Known history of HIV infection
* Tumor not clearly visualized on ultrasound
* No safe ultrasound pathway due to scarring, bowel gas, calcified tumor, or bone interference
* Prior radiotherapy within 30 days before or after treatment
* Arterial calcification in the treatment area
* arterial calcification in the ultrasound treatment area.
* Severe anesthesia intolerance
* Tumor invasion of major vessels, gastrointestinal tract, or respiratory tract
* within systemic infections; tissue ablation is not suitable until the infection is controlled.
* Other contraindications related to the medical device in this trial:
1. Poor tolerance to anesthetics.
2. The target tumor is less than 1 cm from the skin.
3. within severe organ dysfunction, such as heart, liver, kidney, brain, or lung.
4. within severe cachexia, extreme fatigue, or severe ascites.
5. within severe diabetes.
6. The treatment target involves important blood vessels or portal vein thrombosis, or the tumor has invaded the vessel wall or significantly compressed blood vessels.
7. The tumor has invaded the digestive tract or respiratory tract.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07180706
Study Brief:
Protocol Section:
NCT07180706