NCT07207343

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.

Active, enrolled NA Last updated 3 October 2025

What this trial tests

NA trial testing Haifu Focused Ultrasound tumor therapeutic System in Liver Cancer in 38 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 October 2023

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	1 October 2023
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across Taiwan

Drugs / interventions tested

• Haifu Focused Ultrasound tumor therapeutic System

Conditions studied

• Liver Cancer — all drugs for Liver Cancer →
• HIFU — all drugs for HIFU →

Sponsor

National Taiwan University Hospital

Who can join

20 and older, any sex, with Liver Cancer or HIFU. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 chemotherapy or local radiotherapy to delay tumor progression, improve quality of life, and extend survival. For benign tumors, however, there are currently no effective alternative recommendations. For unresectable tumors, local ablation therapies such as radiofrequency ablation (RFA) are considered potential curative options. Nonetheless, the major limitations of RFA include its invasive puncture procedure, which may lead to bleeding or needle-track tumor seeding, and its reduced efficacy for tumors located adjacent to blood vessels, thereby restricting its use mainly to small hepatocellular carcinomas.

High-Intensity Focused Ultrasound (HIFU) is an emerging ablation tool developed in recent years that provides non-invasive treatment for solid tumors. Its therapeutic principle involves focusing ultrasound waves onto a single point within biological tissue, where the concentrated energy generates thermal, mechanical, and cavitation effects that destroy tumor cells. Under real-time monitoring with ultrasound imaging systems, the focal point can be moved across the treatment area through various scanning approaches, thereby ablating the targeted tumor tissue. The ablated tissue will gradually be absorbed and replaced by fibrosis within the body. Since HIFU does not require needle puncture into the body, it is considered non-invasive.

This clinical trial will employ the Haifu Focused Ultrasound Tumor Therapeutic System, which was approved and registered by the Taiwan Ministry of Health and Welfare in 2012 for the ablation of uterine fibroids. The proposed study targets patients with intra-abdominal benign or malignant tumors who are unsuitable for surgical resection but present with tumor-related symptoms. Tumors will be treated with HIFU, postoperative complications will be monitored, treatment response will be evaluated one month after therapy, and patient survival will be followed up to verify the clinical feasibility and safety of this system.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.