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Search / Trial NCT06911528

Application of EndoScell Intraoperative Cellular Probing Technology for Early-Stage Breast Cancer

Launched by FUDAN UNIVERSITY · Mar 28, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Breast Carcinoma Sentinel Lymph Node Tracer Touch Imprint Cytology Epifluorescence Widefield Microscope System

ClinConnect Summary

This clinical trial is studying a new technology called the EndoScell Scanner (ES) that helps doctors quickly and accurately assess the status of sentinel lymph nodes—important areas that can indicate whether breast cancer has spread. The trial aims to see how well this technology works compared to standard methods during surgery for patients with early-stage breast cancer. By using special fluorescent dyes that are safe and non-invasive, the ES can provide detailed images of cells in real-time, allowing for faster results and potentially better treatment planning.

To participate in this study, women aged 18 and older who have been diagnosed with breast cancer and are scheduled for a sentinel lymph node biopsy may be eligible. Participants will need to provide informed consent and must not have allergies to the study dyes or be pregnant or breastfeeding. During the trial, participants can expect to have their sentinel lymph nodes assessed using this new technology, which may help improve the accuracy of their surgical outcomes. The study is currently recruiting, and it's an exciting opportunity to explore a promising advancement in breast cancer treatment.

Gender

FEMALE

Eligibility 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

About Fudan University

Fudan University, a prestigious comprehensive research university located in Shanghai, China, is committed to advancing medical science through innovative clinical research. Renowned for its rigorous academic standards and cutting-edge research facilities, Fudan University plays a pivotal role in the global health landscape by sponsoring a diverse array of clinical trials aimed at improving patient outcomes and addressing pressing medical challenges. Leveraging its multidisciplinary expertise and collaborative networks, the university strives to translate scientific discoveries into practical applications, fostering advancements in healthcare and contributing to the well-being of communities both locally and internationally.

Locations

Shanghai, Shanghai, China

Shanghai, , China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported