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

NCT ID: NCT07029646

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ES group

Use of EndoScell™ intraoperative handheld microscope

Group Type: EXPERIMENTAL

EndoScell™ intraoperative handheld microscope

Intervention Type: 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.

FS group

without the use of EndoScell™ intraoperative handheld microscope

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EndoScell™ intraoperative handheld microscope

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

zhaoqingfan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Fan

Role: CONTACT

zhqfan@bjmu.edu.cn

13601052226

Other Identifiers

BC-P37

Identifier Type: -

Identifier Source: org_study_id