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

C

China Medical University

Status

Enrolling

Conditions

Breast Cancer

Treatments

Device: a high-intensity focused ultrasound tumor treatment system (Super Knife)

Study type

Interventional

Funder types

Other

Identifiers

NCT06210529
MUKDEN 10

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 2 patient groups

Group A (treatmen once)
Experimental group
Treatment:
Device: a high-intensity focused ultrasound tumor treatment system (Super Knife)
Group B (treatmen twice)
Experimental group
Treatment:
Device: a high-intensity focused ultrasound tumor treatment system (Super Knife)

Trial contacts and locations

1

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Central trial contact

Nan Niu, Phd

Data sourced from clinicaltrials.gov

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