Clinical trial · Interventional
High-intensity Focused Ultrasound (HIFU) for the Symptom Relief of Inoperable Abdominal Tumors
To Evaluate the Safety and Efficacy of High-intensity Focused Ultrasound (HIFU) for the Symptom Relief of Inoperable Abdominal Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Symptomatic Abdominal Tumour | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-intensity focused ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High-intensity focused ultrasound therapy
- description
- 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.
- interventionNames
- Device: High-intensity focused ultrasound
Primary outcomes (1)
- measure
- Evaluation of tumour response
- timeFrame
- 1 month after treatment
- description
- Evaluation of tumour response according to the modified RECIST criteria by sequencing CT or MR imaging
Secondary outcomes (1)
- measure
- To evaluate the overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: \- Patients must meet all of the following inclusion criteria to be eligible for this study: 1. Eligible patients with symptomatic intra-abdominal tumor including liver, pancreas, bile duct and retroperitoneal tumors will be enrolled for study. 2. The criteria for unresectability included evidence of distant metastatic disease, involvement of the major vessels and high risk of functional insufficiency after tumor excision. 3. Eastern Cooperative Oncology Group (ECOG) score of 0-1, 4. American Society of Anaesthesiologists (ASA) score ≤ 3, 5. Adequate bone marrow, liver and renal function (1). Platelet count ≥ 100 K/Μl(2). Total bilirubin ≦ 5 mg/dL(3). Alanine transaminase (ALT) and aspartate transaminase (AST) \< 5 x upper limit of normal (4). Prothrombin time (PT)- international normalized ratio (INR) ≦ 2.0 (5). Serum creatinine ≦ 2 x upper limit of normal 6. Prior Informed Consent Form 7. Life expectancy of at least 3 months. Exclusion Criteria: * Patients presenting with any of the following will not be enrolled into this study: 1. The tumor cannot be visualized by abdominal MRI. 2. No suitable approach route for ultrasound toward tumor under image evaluation, for example scar formation, bowel gas, bone within the ultrasound window. 3. Women who are pregnant. 4. The patients had received treatment with an investigational agent/ procedure within 30 days prior to this study. 5. Arterial calcification was noted within the treatment window of ultrasound.
References
Publications (0)
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