Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

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 typeInterventional
Ages18 Years and up
SexWomen only
Enrollment709 (estimated)
SponsorFudan University
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedJanuary 30, 2024
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedApril 4, 2025
Trial IDNCT06911528 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.