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

March 28, 2025 updated by: Jiong Wu, Fudan University

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

Sentinel Lymph Node Biopsy (SLNB) is a common surgical treatment for breast cancer and a primary method for assessing the pathological status of axillary lymph nodes. Precise intraoperative detection of sentinel lymph nodes during surgery assists in timely evaluation of axillary lymph node pathology and helps in formulating further treatment strategies.

Touch imprint cytology (TIC) is one of the most commonly used intraoperative detection techniques. The new intraoperative cellular detection technology, EndoScell Scanner (ES), uses an improved real-time miniaturized fluorescence microscopy system for image acquisition. The ultra-high-resolution images obtained can reach the cellular level. In previous studies, the accuracy and sensitivity of this technology for intraoperative detection of sentinel lymph nodes were comparable to imprint cytology, but it is much more rapid. The detection technology uses fluorescein sodium and methylene blue as fluorescent dyes, which is non-invasive and also non-consumptive of tissue samples.

This study involves patients scheduled for sentinel lymph node biopsy and aims to evaluate the clinical application value of the EndoScell Scanner (ES) for intraoperative assessment of the pathological status of sentinel lymph nodes through a prospective self-controlled study. To avoid the potential impact of methylene blue on the ES detection technology, we will use mitoxantrone as a new dye for sentinel lymph node tracing in this study.

The primary study objective is to compare the accuracy of the ES detection technology in assessing sentinel lymph node status, using paraffin pathology examination as the gold standard. The primary endpoint is the accuracy of the ES technology. Secondary endpoints include the image quality score of the ES detection, the learning curve of the surgeons, and the time required for detection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In recent years, the incidence of breast cancer in China has risen rapidly. Over the past two decades, the annual average incidence rate has increased from 15 per 100,000 to about 30 per 100,000. In first-tier cities like Shanghai, the incidence rate even exceeds 60 per 100,000, making breast cancer the leading malignant tumor threatening women's health. Compared to Western countries, the onset age of breast cancer in Chinese women is relatively younger, with over 54% of cases occurring before menopause. Surgery remains the mainstay of comprehensive treatment for breast cancer. Nearly half of the patients require mastectomy due to the extent or location of the tumor, resulting in significant disfigurement and long-term psychological trauma. In recent years, the demand for postoperative breast appearance among breast cancer patients in China has been increasing, leading to a rise in the proportion of conventional breast-conserving surgery, breast-conserving surgery, and various types of breast reconstruction surgeries.

Breast-conserving surgery combined with postoperative radiotherapy can improve the postoperative breast appearance and quality of life while achieving tumor safety equal to or even better than that of total mastectomy. Breast-conserving oncoplastic surgery, which combine the principles of conventional breast conservation with plastic surgery techniques, further enhance the feasibility and safety of breast-conserving surgery.

The development of breast-conserving oncoplastic surgery has created a more urgent need to ensure negative margins intraoperatively. Despite expanding surgical indications due to the application of oncoplastic techniques, the positive margin rate of breast-conserving oncoplastic surgery is not significantly different from that of conventional breast-conserving surgery, ranging from 5% to 15%. Although re-excision after a positive margin does not affect local recurrence risk, it significantly diminishes postoperative cosmetic outcomes. More importantly, the design of oncoplastic surgery incisions becomes a challenge if mastectomy is needed based on margin status. Currently, the most accurate method for margin assessment is postoperative margin staining followed by radial sectioning and paraffin pathology examination. To enable timely intraoperative margin assessment, various methods have been proposed, including intraoperative frozen section analysis, specimen X-ray photography, and micro-computed tomography. However, these methods require ex vivo specimen evaluation and have limited sensitivity. Small sample studies have used micro-PET/CT technology for specimen imaging, but its high cost prevents widespread clinical validation and application.

The EndoScell Scaner (ES) is a novel intraoperative cell detection technology that uses a modified real-time miniaturized fluorescence microscope system for image acquisition, achieving ultra-high resolution at the cellular level. Previous studies have shown that its accuracy and sensitivity in intraoperative sentinel lymph node detection are comparable to those of cytological imprinting but with greater speed. This technology employs sodium fluorescein and methylene blue as fluorescent dyes, is non-invasive, and does not consume tissue samples.

This study aims to evaluate the clinical value of the EndoScell Scaner (ES) novel intraoperative cell probing technology for intraoperative margin assessment in patients undergoing conventional breast-conserving surgery and breast-conserving oncoplastic surgery combined with sentinel lymph node biopsy. The primary objective is to compare the accuracy of ES technology in assessing margin status and sentinel lymph node status using paraffin pathology as the gold standard. The primary endpoints are the accuracy of ES technology, positive margin rate, and reoperation rate; the secondary endpoints are ES detection image quality score, learning curve of surgeons, and detection time.

Study Type

Interventional

Enrollment (Estimated)

709

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraoperative Assessment
After screening and enrollment, the EndoScell Scaner (ES) novel intraoperative cellular probing technology will be used for intraoperative evaluation of the sentinel lymph node. Concurrently, imprint cytology will be performed for evaluation. During the study period, intraoperative decisions will primarily reference the results of the imprint cytology technique.
Procedure: EndoScell Scaner (ES) novel intraoperative cellular probing technology
In this project, we utilize the miniature wide-angle focusing microscope for intraoperative cell-level observation and detection, a technology in which our hospital has conducted extensive research and accumulated rich experience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of ES technology
Time Frame: After the final pathological results are obtained, it is usually about 2 weeks after surgery
the accuracy of the ES technology （including accuracy, sensitivity and specificity）
After the final pathological results are obtained, it is usually about 2 weeks after surgery
The reoperation rate
Time Frame: 3 months after surgery
The proportion of reoperations due to a positive margin
3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The quality score of ES imaging
Time Frame: After the final pathological results are obtained, it is usually about 2 weeks after surgery
The image quality of ES was scored by the pathologist
After the final pathological results are obtained, it is usually about 2 weeks after surgery
The learning curve of the surgeons
Time Frame: through study completion, an average of 1 year
Evaluate the number of cases required for the surgeon to achieve 95% or more accuracy
through study completion, an average of 1 year
The time required for the intraoperative evaluation
Time Frame: through study completion, an average of 1 year
The time required for intraoperative detection using ES technology
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDGE
  • HYXH2024012 (Other Grant/Funding Number: Shanghai Anticancer Development Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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