Clinical Study of High-intensity Focused Ultrasound Tumor Treatment System(Super Knife) in the Treatment of Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Device: a high-intensity focused ultrasound tumor treatment system (Super Knife)
- Registration Number
- NCT06210529
- Lead Sponsor
- Shengjing Hospital
- Brief Summary
Breast cancer is the most common cancer diagnosed among women and is the second leading cause of cancer death among women after lung cancer. The treatment methods of breast cancer include surgery, chemotherapy, radiotherapy and so on. The investigators discover a High-intensity focused ultrasound therapy to treat breast tumor, which is a non-invasive method.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 12
ECOG Performance Status of 0-1; Histological confirmed invasive breast cancer; Breast cancer tumor measuring ≥2 cm in maximal diameter and a single lesion as measured by mammogram, breast ultrasound, or breast MRI; Breast tumor's borders from the skin are greater than 1 cm; No lymph node or distant metastasis; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, Platelets ≥ 50 × 109/L, Hemoglobin ≥ 9.0 g/dl iv; Serum creatinine ≤1.5 x upper limit of normal (ULN); AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN; Left ventricular ejection fraction ≥ 50%.
Inflammatory breast cancer, bilateral breast cancer, or occult breast cancer; Any kind of prior treatment for breast cancer, including chemotherapy, radiotherapy, endocrine therapy and so on; Pregnant and lactating women; Patients who have participated in other clinical trials.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B (treatmen twice) a high-intensity focused ultrasound tumor treatment system (Super Knife) - Group A (treatmen once) a high-intensity focused ultrasound tumor treatment system (Super Knife) -
- Primary Outcome Measures
Name Time Method Pathological complete response (pCR) 1 month after surgery pCR is defined as the absence of residual invasive cancer in the breast and the lymph nodes.
- Secondary Outcome Measures
Name Time Method Objective response rate In the first month, the second month, the third month The percentage of patients whose therapeutic intervention has led to a complete response, partial response.
Disease control rate In the first month, the second month, the third month The percentage of patients whose therapeutic intervention has led to a complete response, partial response, or stable disease.
Adverse events 1 month after surgery Adverse events during and after the treatment
Trial Locations
- Locations (1)
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China