Using advanced imaging technology for early-stage breast cancer surgery
Official title: 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
Run by Fudan University · NCT06911528 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 709 (estimated) |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | January 30, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | April 4, 2025 |
| Trial ID | NCT06911528 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with allergies to the fluorescent dyes used or those who are pregnant or lactating may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown comparable accuracy and sensitivity of similar intraoperative detection technologies, suggesting potential for success with this novel approach.
Who can join: the full rules
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 it's running
-
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Jiajian Chen, Doctor
- Email: elwin1020@163.com
- Phone: +8618017317219
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using indocyanine green to find sentinel lymph nodes during mastectomy
This pilot will test whether injecting indocyanine green and using fluorescence during mastectomy can find sentinel lymph nodes in women with clinically node-negative invasive breast cancer.
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Using indocyanine green to identify sentinel lymph nodes during breast cancer surgery
This project tests whether indocyanine green dye and a fluorescence camera can be used instead of the radioactive tracer to find sentinel lymph nodes in adults having breast cancer surgery who are clinically node-negative.
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This study is testing a new imaging technology to help doctors better identify breast cancer and check lymph nodes during surgery for patients with breast cancer.
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This study is testing if some early breast cancer patients can skip certain surgeries to remove lymph nodes, which might help them avoid unnecessary complications and costs.
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Using a low dose of Magtrace to locate lymph nodes in breast cancer patients
This study is testing if a low dose of a new tracer can help find lymph nodes in breast cancer patients as well as the traditional methods do.
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Avoiding sentinel lymph node biopsy in early breast cancer patients
This study is testing whether women with early breast cancer can safely skip a specific lymph node surgery to see if it helps them recover better and have less swelling in their arms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.