Precise lymph node biopsy system for breast cancer treatment
Clinical Study on Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer
This study is testing a new way to do lymph node biopsies for early-stage breast cancer to see if it can improve surgery results and reduce complications compared to the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT03857932 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on improving the sentinel lymph node biopsy (SLNB) technique for patients with early-stage breast cancer by utilizing preoperative computed tomographic lymphography. The study aims to accurately identify sentinel lymph nodes and their drainage patterns to enhance surgical outcomes and minimize unnecessary lymph node removals. Participants will be randomized into two groups: one receiving the precise SLNB with additional non-sentinel lymph node resection, and the other receiving standard SLNB. The goal is to reduce treatment-related complications while ensuring effective cancer management.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed early-stage breast cancer who have abnormal para-sentinel lymph nodes but negative fine needle aspiration cytology results.
Not a fit: Patients with ductal carcinoma in situ or those who have received neo-adjuvant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgical interventions and better outcomes for breast cancer patients.
How similar studies have performed: Other studies have shown promise in improving SLNB techniques, but this specific approach utilizing computed tomographic lymphography is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy 2. abnormal para-sentinel lymph node was found by ultrasound examination 3. ultrasound-guided fine needle aspiration cytology of these nodes were performed 4. the result of fine needle aspiration cytology was negative (no tumour cell was found) 5. participants planed to perform SLNB Exclusion Criteria: 1. pathological diagnosed ductal carcinoma in situ by excisional biopsy 2. the result of fine needle aspiration cytology was positive 3. participants has received neo-adjuvant system therapy
Where this trial is running
Jinan, Shandong
- Qifeng Yang — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Qifeng Yang — Qilu Hospital, Shandong University
- Study coordinator: Qifeng Yang
- Email: qifengy_sdu@163.com
- Phone: +8618560085168
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.