Using advanced imaging technology for early-stage breast cancer surgery
A Prospective Study to Evaluate the Application of EndoScell Intraoperative Cellular Probing Technology in Breast Conserving Therapy and Sentinel Lymph Node Biopsy for Early-Stage Breast Cancer
This study is testing a new imaging tool during breast cancer surgery to see if it can help doctors find lymph nodes more accurately and improve treatment for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 709 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06911528 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the EndoScell Scanner, a novel intraoperative cellular probing technology, for detecting sentinel lymph nodes during breast cancer surgery. The technology utilizes real-time fluorescence microscopy to provide ultra-high-resolution images, allowing for rapid and accurate assessment of lymph node pathology. By improving the detection process, the study aims to enhance surgical outcomes and inform subsequent treatment strategies for patients undergoing sentinel lymph node biopsy. The trial is particularly relevant given the rising incidence of breast cancer in China and the increasing demand for breast-conserving surgical options.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with confirmed invasive breast carcinoma or ductal carcinoma in situ who are scheduled for sentinel lymph node biopsy.
Not a fit: Patients with allergies to the fluorescent dyes used or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could lead to more accurate and timely surgical decisions, potentially improving patient outcomes and quality of life.
How similar studies have performed: Previous studies have shown comparable accuracy and sensitivity of similar intraoperative detection technologies, suggesting potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years and older (inclusive) * Female * Preoperative pathology confirmed invasive breast carcinoma or ductal carcinoma in situ * Scheduled for sentinel lymph node biopsy * Capable of and willing to provide informed consent Exclusion Criteria: * Patients with a confirmed allergy to methylene blue or sodium citrate tracers * Pregnant or lactating women * Patients unwilling to participate in the clinical study
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jiajian Chen, Doctor
- Email: elwin1020@163.com
- Phone: +8618017317219
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.