Using carbon dye to mark lymph nodes before chemotherapy in breast cancer patients
Feasibility of Carbon Dye Marking of Axillary Lymph Nodes Before Neoadjuvant Chemotherapy in Patients With Breast Cancer
This study is testing whether using carbon dye to mark lymph nodes before chemotherapy can help improve surgery results for breast cancer patients with advanced disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Gaziosmanpasa Research and Education Hospital Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT05735795 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of marking axillary lymph nodes with carbon dye prior to administering neoadjuvant chemotherapy in patients with locally advanced breast cancer. The approach aims to improve the accuracy of lymph node evaluation and reduce false-negative rates during subsequent surgical procedures. By utilizing targeted axillary dissection, the study seeks to enhance surgical outcomes for patients who initially present with axillary lymph node metastases. The methodology involves identifying and marking lymph nodes that are known to contain metastatic disease before treatment begins.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with locally advanced breast cancer who have confirmed metastases to the axillary lymph nodes and are scheduled for neoadjuvant chemotherapy.
Not a fit: Patients who have undergone previous axillary surgery or those diagnosed by excisional biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate surgical interventions and better outcomes for breast cancer patients with lymph node involvement.
How similar studies have performed: Previous studies have shown that targeted axillary dissection can reduce false-negative rates in similar patient populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with locally advanced breast cancer known to have metastases to the axillary lymph nodes at baseline and referred for neoadjuvant chemotherapy will be included in the study. Exclusion Criteria: * diagnosis by excisional biopsy * previous axillary surgery * failure to complete neoadjuvant therapy * progression during therapy.
Where this trial is running
Istanbul
- Gaziosmanpasa Training and Research Hospital — Istanbul, Turkey (Recruiting)
Study contacts
- Principal investigator: Emine Yildirim, Assoc. Prof. — Gaziosmanpasa Training and Research Hospital
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.