Cellular-Level Fluorescence Imaging for Intraoperative Margin Assessment in Breast Cancer
NCT ID: NCT07311317
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
165 participants
OBSERVATIONAL
2026-01-31
2027-01-31
Brief Summary
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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.
Detailed Description
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Data Collection:1)Basic patient information: age, gender; 2)Tumor diagnosis (including imaging diagnosis): location, size, and staging; 3)Intraoperative collected information: surgery start time, surgery end time; 4)Training and testing records of the physicians in the ES interpretation group; 5)Interpretation records: a.ES start time, ES interpretation end time, ES interpretation results, ES image satisfaction; b.Frozen pathology submission time, report receipt time, report results; c.Paraffin pathology submission time, report time, and report results.
The statistical analysis will be performed using SAS statistical software, version 9.4 or higher. All statistical tests will be two-sided. A P value less than or equal to 0.05 will be considered statistically significant. The description of quantitative indicators will include the mean, standard deviation, median, minimum, maximum, and interquartile range. The description of categorical indicators will use the number and percentage of each category. The comparison of general conditions between the two groups will be analyzed using appropriate methods based on the type of indicators. The consistency evaluation of quantitative data will use the Bland-Altman method and ICC.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients scheduled for breast tumor resection
* Clinically or radiologically showing a solitary lesion and
1. (Before neoadjuvant chemotherapy) Maximum tumor diameter ≤ 5cm;
2. cN0-1;
3. 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.
Exclusion Criteria
* 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.
18 Years
70 Years
FEMALE
No
Sponsors
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West China Fourth Hospital, Sichuan University
UNKNOWN
The Fourth People's Hospital of Sichuan Province
UNKNOWN
West China Hospital
OTHER
Responsible Party
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Du Zhenggui
deputy director of breast center
Locations
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the Fourth People'S Hospital of Sichuan Province
Chengdu, , China
West China Fourth Hospital, Sichuan University
Chengdu, , China
West China Hospital
Chengdu, , China
Countries
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Central Contacts
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Facility Contacts
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donglin zhang
Role: primary
bin ma
Role: primary
zhenggui Du
Role: primary
Other Identifiers
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2025-1955
Identifier Type: -
Identifier Source: org_study_id