High-intensity Focused Ultrasound (HIFU) for the Symptom Relief of Inoperable Abdominal Tumors (HIFU)
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|ClinicalTrials.gov Identifier: NCT03152695|
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : August 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Abdominal Tumour||Device: High-intensity focused ultrasound||Not Applicable|
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 the tumor response after a month and track the survival rate to verify the feasibility and advantages of HIFU for clinical use.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||To Evaluate the Safety and Efficacy of High-intensity Focused Ultrasound (HIFU) for the Symptom Relief of Inoperable Abdominal Tumors|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: High-intensity focused ultrasound therapy
Abdominal MRI will be used to target the tumor, and the tumor will be divided into slices with 5mm separation using MR images. By scanning the HIFU beam in successive sweeps from the deep to the shallow regions of the tumor.
Device: High-intensity focused ultrasound
Local tumor ablation by ArcBlate (EpiSonica, Taiwan) will be performed, and the entire procedure will be monitored by MRI
- Evaluation of tumour response [ Time Frame: 1 month after treatment ]Evaluation of tumour response according to the modified RECIST criteria by sequencing CT or MR imaging
- To evaluate the overall survival [ Time Frame: within one year ]using Common Terminology Criteria for Adverse Events (CTCAE). Version 4.0 and overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152695
|Contact: Kai-Wen Huang, MD, PhDemail@example.com|
|National Taiwan University Hospital||Recruiting|
|Contact: Kai-Wen Huang, MD, PhD firstname.lastname@example.org|
|Principal Investigator:||Kai-Wen Huang, MD, PhD||National Taiwan University Hospital|