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Clinical Study of High-intensity Focused Ultrasound Tumor Treatment System(Super Knife) in the Treatment of Breast Cancer

Clinical Study of High-intensity Focused Ultrasound Tumor Treatment System(Super Knife) in the Treatment of Breast Cancer

Recruiting
18-75 years
Female
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

        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%.
        Exclusion Criteria:
        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 details
    Breast Cancer

NCT06210529

Shengjing Hospital

27 January 2024

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