Clinical Trial: High-intensity Focused Ultrasound (HIFU) for the Symptom Relief of Inoperable Abdominal Tumors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: To Evaluate the Safety and Efficacy of High-intensity Focused Ultrasound (HIFU) for the Symptom Relief of Inoperable Abdominal Tumors

Brief Summary: High-intensity focused ultrasound (HIFU), a recently developed tumor ablation equipment, can be a non-invasive treatment for solid tumors. The principle of HIFU is physically focus the ultrasound point on the biological tissue to form high-intensity ultrasound focus, and kill tumor cells by the thermal effects, mechanical effects and acupuncture effects of the high-intensity ultrasound.

Detailed Summary:

The clinical recommendations for unresectable malignant tumors, which cause pain and other symptoms, are chemotherapy or local radiation therapy to delay tumor progression, improve life quality and prolong survival, while there is no other effective recommendations for benign tumors., Local ablation, such as radiofrequency ablation (RFA), is expected to be another therapeutic option for tumors that cannot be surgically resected. However, the main drawback of radiofrequency ablation is that its puncture invasion can sometimes cause bleeding or tumor metastasis. The peripheral blood vessels can also cause poor ablation, therefore; RFA is limited to small liver cancer treatment.

High-intensity focused ultrasound (HIFU), a recently developed tumor ablation equipment, can be a non-invasive treatment for solid tumors. The principle of HIFU is physically focus the ultrasound point on the biological tissue to form high-intensity ultrasound focus, and kill tumor cells by the thermal effects, mechanical effects and acupuncture effects of the high-intensity ultrasound.

Under the real-time magnetic resonance imaging system and a variety of appropriate scanning to move the focused ultrasound in the treatment area to kill the tumor. The tumor that is killed will gradually absorb and fibrosis in the body. There is no significant invasion due to it is without penetrating the needle into body. This system has been approved and certificated for the use of soft tissue ablation by Taiwan Food and Drug Administration (TFDA) in 2016. The main participants of this study are patients who have benign and malignant tumors in the abdominal cavity with tumor-related symptoms and not suitable for surgical resection. The investigators will conduct HIFU, observe whether there is any complications after surgery. Moreover, the investigators will notice th
Sponsor: National Taiwan University Hospital

Current Primary Outcome: To evaluate the efficacy of HIFU for the treatment of symptomatic abdominal tumour patients [ Time Frame: up to three years ]

evaluation of tumour response


Original Primary Outcome: Same as current

Current Secondary Outcome: To evaluate the safety of HIFU [ Time Frame: within one year ]

using Common Terminology Criteria for Adverse Events (CTCAE). Version 4.0 and - overall survival


Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: May 11, 2017
Date Started: May 2017
Date Completion: December 2019
Last Updated: May 11, 2017
Last Verified: January 2017