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

Breast Cancer Clinical Trial

Official title:

A Single-center, Prospective Clinical Study of High-intensity Focused Ultrasound Tumor Treatment System(Super Knife) in the Treatment of Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06210529
• Other study ID #: MUKDEN 10
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Shengjing Hospital
• Contact: Nan Niu, Phd
• Phone: +8618940256668
• Email: niunannancy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• a high-intensity focused ultrasound tumor treatment system (Super Knife)
All participants will be randomly divided into groups A and B. Participants in group A will receive a high-intensity focused ultrasound tumor treatment (Super Knife) once, and participants in group B will receive treatment twice (4 weeks, one cycle).. Breast cancer surgery was performed at 3 months ± 1 week after the Super Knife treatment.

Locations

Country	Name	City	State
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response (pCR)	pCR is defined as the absence of residual invasive cancer in the breast and the lymph nodes.	1 month after surgery
Secondary	Disease control rate	The percentage of patients whose therapeutic intervention has led to a complete response, partial response, or stable disease.	In the first month, the second month, the third month
Secondary	Objective response rate	The percentage of patients whose therapeutic intervention has led to a complete response, partial response.	In the first month, the second month, the third month
Secondary	Adverse events	Adverse events during and after the treatment	1 month after surgery