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Cellular-Level Fluorescence Imaging for Intraoperative Margin Assessment in Breast Cancer

NCT07311317 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 165

Last updated 2025-12-30

No results posted yet for this study

Summary

Accurate intraoperative margin assessment in breast cancer surgery remains challenging. Current reliance on frozen section pathology is limited by prolonged processing time, sampling constraints, and resource intensity, contributing to variable outcomes.

The EndoSCell Scanner is a novel cellular-resolution fluorescence-guided imaging technology designed to address these limitations. It enables real-time, pathology-level visualization of malignant cellular features at the surgical bed. With a 3mm probe allowing comprehensive 360° margin assessment, it reduces procedural time to under five minutes and may significantly lower secondary surgery rates.

This prospective, self-controlled study aims to evaluate the accuracy of the EndoSCell Scanner for intraoperative margin assessment in patients undergoing mastectomy. Its performance will be systematically compared against both frozen section and final paraffin pathology to validate sensitivity and operational efficiency. If proven effective, this technology could become a standard adjunct tool, standardizing precision in breast cancer surgery and improving patient outcomes by enhancing surgical consistency.

Conditions

  • Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Sponsors & Collaborators

  • West China Fourth Hospital, Sichuan University

    collaborator UNKNOWN

  • The Fourth People's Hospital of Sichuan Province

    collaborator UNKNOWN

  • West China Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07311317 on ClinicalTrials.gov