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

NCT07311317 | Not Yet Recruiting DMC

• 1 other identifier: 2025-1955
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 3

Brief 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)

Keywords

Breast Cancer,; Fluorescence-guided; Cellular

Outcome Measures

Primary Outcomes (1)

• To evaluate the sensitivity and specificity of the EndoSCell Scanner (ES) detection, using paraffin pathology as the gold standard, in comparison to rapid frozen section (FS) pathology.

  3 month

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll 165 adult female patients scheduled to undergo breast surgery for histologically confirmed breast cancer. Eligible participants must provide written informed consent.

You may qualify if:

• Age between 18 - 70 years
• Patients scheduled for breast tumor resection
• Clinically or radiologically showing a solitary lesion and
• (Before neoadjuvant chemotherapy) Maximum tumor diameter ≤ 5cm;
• cN0-1;
• No clinical or imaging evidence of nipple, skin, chest wall invasion, or distant metastasis before surgery.
• Subjects voluntarily sign informed consent or are exempted from signing upon approval by the ethics committee.

You may not qualify if:

• Inflammatory breast cancer;
• Patients allergic to methylene blue and sodium fluorescein;
• Unable to understand the trial requirements or unable to complete the study follow-up plan;
• Pregnant and breastfeeding women;
• Patients unable to complete follow-up due to mental illness, cognitive or emotional disorders;
• Those with severe comorbidities (such as organ dysfunction, immune deficiency) or poor general condition;
• Those participating in other clinical studies that may affect this trial;
• Those for whom satisfactory specimens for both frozen pathology and paraffin pathology cannot be obtained during surgery;
• Those who cannot obtain a paraffin pathology report.

Sponsors & Collaborators

• West China Hospital: lead
• The Fourth People's Hospital of Sichuan Province: collaborator

Study Sites (3)

the Fourth People'S Hospital of Sichuan Province

Chengdu, China

Location

West China Fourth Hospital, Sichuan University

Chengdu, China

Location

West China Hospital

Chengdu, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zhenggui DU

CONTACT

+86 13880768222; docduzg@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy director of breast center

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CN (3)