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

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.

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Key information

Conditions

Breast-conserving Surgery Breast Carcinoma Breast Diseases Breast Neoplasms Margins in the Specimen Margins of Excision Morphological and Microscopic Findings Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Accuracy

Time frame: Within 7 days after the operation

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

Study contacts

Contact information is provided by the study sponsor or research team.

Fan

CONTACT

[email protected]

13601052226

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jun 19, 2025
Registry last updated: Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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