Actively Recruiting
A Single-center, Single-arm, Open Study on the Treatment of Early Small Breast Cancer With Ultrasound-guided Vacuum-assisted Excision Combined With Surgery
Led by Xijing Hospital · Updated on 2025-08-15
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of ultrasound-guided vacuum-assisted excision (VAE) combined with surgery for treating early small breast cancer, specifically carcinoma in situ (Tis) or tumors up to 2 cm (T1) with no signs of lymph node involvement. The study aims to understand the complete removal rate of cancerous lesions by VAE, identify which breast cancer types respond best, and assess the safety and complication rates of this approach. It also explores whether patients diagnosed with cancer after VAE still need further surgery. Participants first undergo VAE, where ultrasound guides a needle to remove the tumor tissue under local anesthesia. If cancer is confirmed, patients then receive standard surgical treatment such as breast-conserving surgery or total mastectomy, along with sentinel lymph node biopsy. The removed tissues from both procedures are examined pathologically to check for complete tumor removal and other characteristics. The study is single-arm and conducted at one center. Participants are screened and enrolled based on specific breast cancer imaging and clinical criteria. They are monitored for complications like bleeding or infection during and after procedures. Follow-up includes evaluating patient satisfaction and quality of life at 1 week, 1 month, 3 months, and 6 months. The primary outcome is the complete removal rate of lesions after VAE, with secondary outcomes including complication rates, local recurrence over two years, and patient satisfaction. The study duration extends over several years with detailed data collection and assessments.
CONDITIONS
Brief Title
A Study on the Treatment of Early Small Breast Cancer With Ultrasound-guided Vacuum-assisted Excision Combined With Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old
- Female patients
- Suspected breast cancer diagnosed by imaging with BI-RADS Category 4C or 5
- Clinical stage T1 with tumor size 2 cm or less
- No prior breast cancer treatment
- Willing to undergo ultrasound-guided vacuum-assisted resection, biopsy, and surgery
- Voluntarily agree to participate and sign informed consent
You will not qualify if you...
- Lesion larger than 2 cm on imaging
- Suspected positive axillary lymph nodes on imaging
- Tumor invading nipples, areolas, or subcutaneous tissues
- Breast cancer diagnosed during pregnancy
- Poorly controlled vital organ dysfunction or diabetes preventing surgery
- Any other condition making participation unsuitable as judged by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo ultrasound-guided vacuum-assisted excision to remove the tumor tissue under local anesthesia with ultrasound guidance. The tissue is then sent for pathological examination.
1 procedure visit (in-person)
Duration - 1 day
Participants who are confirmed to have breast cancer from the excision undergo radical mastectomy surgery, which may include breast-conserving surgery or total mastectomy with sentinel lymph node biopsy.
1 surgery visit (in-person)
Duration - 6 months
Participants receive pathological assessment of the surgical specimens and are monitored for surgery-related complications. Satisfaction and quality of life are evaluated at 1 week, 1 month, 3 months, and 6 months after surgery. Additional treatment such as chemotherapy, targeted therapy, endocrine therapy, or radiotherapy may be given as clinically indicated.
Visits at 1 week, 1 month, 3 months, and 6 months post-surgery
Trial Site Locations
Total: 1 location
1
Xijing hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
J
Ju liang J L Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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