Status:
ACTIVE_NOT_RECRUITING
Symptomatic Abdominal Tumors Are Unsuitable for Surgical Resection, High-intensity Focused Ultrasound (HIFU) Treatment Will be Applied to the Tumors. Postoperatively, Continuous Evaluation and Analysis of the Ablation Effect Will be Performed Using CT or MRI Imaging.
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Liver Cancer
HIFU
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
Solid tumors may cause symptoms such as pain due to compression or space-occupying effects. For patients unsuitable for surgical resection, the primary clinical recommendation for malignant tumors is ...
Eligibility Criteria
Inclusion
- Age ≥ 20 years.
- Ability to understand and comply with the routine care requirements of this trial and provide signed informed consent.
- Patients with intra-abdominal tumors measuring 3-10 cm in diameter, such as hepatobiliary and pancreatic cancers, or benign/malignant retroperitoneal tumors, who present with tumor-related symptoms or discomfort.
- Patients deemed unsuitable for surgical resection due to distant metastasis, vascular or vital organ invasion, or the high risk of impaired organ function if resection were performed.
- Good general condition with an ECOG (Eastern Cooperative Oncology Group) performance status of 0-1, and an ASA (American Society of Anesthesiology) score \< 3.
- No severe hepatic or renal dysfunction (Child-Pugh class A/B); total bilirubin ≤ 5 mg/dL; ALT and AST ≤ 5 × upper limit of normal; serum creatinine ≤ 2 × upper limit of normal.
- Normal coagulation function: PT-INR ≤ 2.0, platelet count ≥ 100,000.
- Estimated survival of more than 3 months.
- Maximum tumor depth from skin surface ≤ 11 cm.
Exclusion
- Tumors that cannot be clearly localized under ultrasound examination.
- No safe acoustic pathway for ultrasound to reach the tumor site upon imaging evaluation, such as when the pathway includes skin scars, bowel gas, calcified tumors, or bones that interfere with ultrasound transmission.
- Pregnant women.
- Participation in any other tumor-related clinical trial within 30 days prior to treatment.
- Radiotherapy to the focused ultrasound treatment area within 30 days before or after treatment.
- Presence of arterial calcification within the treatment area.
- Requirement for systemic pharmacological treatment within two weeks before or after the procedure.
- Deemed unsuitable for treatment by the principal investigator.
- Presence of surgically related metallic implants in the body.
- Inability to undergo CT/MRI examinations.
- Other contraindications related to the investigational device:
- Poor tolerance to anesthetic agents
- Target tumor located less than 1 cm from the skin surface
- Severe dysfunction of vital organs (heart, liver, kidney, brain, or lung)
- Severe systemic disorders, extreme fatigue, or significant ascites
- Severe diabetes mellitus
- Presence of skin ulceration or impending ulceration
- Target lesion involving major vessels or portal vein thrombosis, or tumors invading vessel walls or causing significant vascular compression
- Tumor invasion into the gastrointestinal or respiratory tract
- Tumor with active infection, unless the infection has been controlled
- Patients with severe collagenosis
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT07207343
Start Date
October 1 2023
End Date
December 31 2026
Last Update
October 3 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100