Sound waves offer hope for painful tumors without surgery
NCT ID NCT07207343
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a non-invasive treatment called High-Intensity Focused Ultrasound (HIFU) for people with abdominal tumors that cannot be surgically removed. The goal is to relieve symptoms like pain and improve quality of life. About 38 participants will receive the treatment and be monitored for side effects and tumor response.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 38 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 20 years. 2. Ability to understand and comply with the routine care requirements of this trial and provide signed informed consent. 3. 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. 4. 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. 5. Good general condition with an ECOG (Eastern Cooperative Oncology Group) performance status of 0-1, and an ASA (American Society of Anesthesiology) score \< 3. 6. 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. 7. Normal coagulation function: PT-INR ≤ 2.0, platelet count ≥ 100,000. 8. Estimated survival of more than 3 months. 9. Maximum tumor depth from skin surface ≤ 11 cm. Exclusion Criteria: 1. Tumors that cannot be clearly localized under ultrasound examination. 2. 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. 3. Pregnant women. 4. Participation in any other tumor-related clinical trial within 30 days prior to treatment. 5. Radiotherapy to the focused ultrasound treatment area within 30 days before or after treatment. 6. Presence of arterial calcification within the treatment area. 7. Requirement for systemic pharmacological treatment within two weeks before or after the procedure. 8. Deemed unsuitable for treatment by the principal investigator. 9. Presence of surgically related metallic implants in the body. 10. Inability to undergo CT/MRI examinations. 11. Other contraindications related to the investigational device: 1. Poor tolerance to anesthetic agents 2. Target tumor located less than 1 cm from the skin surface 3. Severe dysfunction of vital organs (heart, liver, kidney, brain, or lung) 4. Severe systemic disorders, extreme fatigue, or significant ascites 5. Severe diabetes mellitus 6. Presence of skin ulceration or impending ulceration 7. Target lesion involving major vessels or portal vein thrombosis, or tumors invading vessel walls or causing significant vascular compression 8. Tumor invasion into the gastrointestinal or respiratory tract 9. Tumor with active infection, unless the infection has been controlled 10. Patients with severe collagenosis
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Taiwan University Hospital
Taipei, 100, Taiwan
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Other studies related to the condition(s) this trial covers.
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