Comparative Research on the Accuracy of Margin Interpretation in Breast-Conserving Surgery for Breast Cancer: Cell Microscopic Imaging and Standard Frozen Pathology

NCT07029646 | Not Yet Recruiting

• 1 other identifier: BC-P37
• Study Type: interventional
• Target: 167
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to assess whether cell microscopic imaging can accurately determine the tumor-free status of surgical margins in breast cancer patients undergoing breast-conserving surgery. This study involves female patients aged 18-70 years with breast cancer who are candidates for breast-conserving surgery. The main question it aims to answer is: \- Can cell microscopic imaging provide accurate intraoperative assessment of surgical margins compared to standard frozen pathology? Researchers will compare the results of cell microscopic imaging to those of standard frozen pathology and paraffin pathology to see if the new imaging technology can effectively and quickly determine whether surgical margins are free of cancer cells. Participants will:

• Undergo breast-conserving surgery with standard pathological assessments.
• Have their surgical margins evaluated using cell microscopic imaging during the operation.
• Be monitored for postoperative recovery at regular intervals (2 weeks, 3 months, 6 months, and 12 months) after the surgery.

Conditions

Breast-Conserving Surgery; Breast Carcinoma; Margins in the Specimen

Keywords

Breast-Conserving Surgery; Breast Cancer; Margins; microscope

Outcome Measures

Primary Outcomes (1)

• Accuracy

  Compare the results of cell microscopic imaging to those of standard frozen section and paraffin section pathology to determine the accuracy and potential advantages of the new imaging technology in real-time intraoperative assessment of surgical margins

  Within 7 days after the operation

Study Arms (2)

ES group

EXPERIMENTAL

Use of EndoScell™ intraoperative handheld microscope

Device: EndoScell™ intraoperative handheld microscope

FS group

NO INTERVENTION

without the use of EndoScell™ intraoperative handheld microscope

Interventions

EndoScell™ intraoperative handheld microscope DEVICE

The research instrument used is the EndoScell™ intraoperative handheld microscope, which employs the principle of epifluorescence. It is a miniaturized microscope that reduces the size of a traditional large optical microscope by approximately a thousand times. It is the world's first handheld micrometer-level intraoperative real-time cell imaging probe microscope. This microscope is equipped with high-definition, real-time, anti-shake, and full-coverage scanning features. It can rapidly investigate the structure and cell morphology of tissues in real-time.

ES group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 70 years old;
• Clinical or imaging showed a single lesion with no evidence of distant metastasis;
• No invasion of the skin, subcutaneous tissue, pectoralis major muscle, and nipple-areola complex;
• Breast cancer patients who are willing to undergo breast-conserving surgery;
• Subjects voluntarily signed the informed consent form.

You may not qualify if:

• Allergic constitution;
• Chest wall or skin invasion, locally advanced breast cancer;
• Extensive axillary lymph node metastasis (stage ⅢB and above);
• Patients with severe complications (such as organ dysfunction, immunodeficiency) and poor general condition;
• Unable to accept general anesthesia or surgical treatment;
• Participating in other clinical studies that may affect this trial;
• Patients who cannot send frozen pathology and paraffin pathology specimens for examination during surgery.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

MeSH Terms

Conditions

Breast Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fan

CONTACT

13601052226; zhqfan@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: July 1, 2025
• Primary Completion: June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06