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

NCT06911528 | Recruiting

• 2 other identifiers: EDGEHYXH2024012
• Study Type: interventional
• Target: 709
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Sentinel Lymph Node; Frozen Section; Cytology

Keywords

Breast carcinoma; sentinel lymph node; tracer; touch imprint cytology; epifluorescence widefield microscope system

Outcome Measures

Primary Outcomes (2)

• The accuracy of ES technology

  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

  The proportion of reoperations due to a positive margin

  3 months after surgery

Secondary Outcomes (3)

• The quality score of ES imaging

  After the final pathological results are obtained, it is usually about 2 weeks after surgery

• The learning curve of the surgeons

  through study completion, an average of 1 year

• The time required for the intraoperative evaluation

  through study completion, an average of 1 year

Study Arms (1)

Intraoperative Assessment

EXPERIMENTAL

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

Interventions

EndoScell Scaner (ES) novel intraoperative cellular probing technology PROCEDURE

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.

Intraoperative Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with a confirmed allergy to methylene blue or sodium citrate tracers
• Pregnant or lactating women
• Patients unwilling to participate in the clinical study

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jiajian Chen, Doctor

CONTACT

+8618017317219; elwin1020@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 4, 2025
• Study Start: January 30, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)