Breast-Conserving SurgeryNCT07029646
Comparative Research on the Accuracy of Margin Interpretation in Breast-Conserving Surgery for Breast Cancer: Cell Microscopic Imaging and Standard Frozen Pathology
A study testing EndoScell™ intraoperative handheld microscope in people with Breast-Conserving Surgery and Breast Carcinoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast-Conserving Surgery, Breast Carcinoma, Margins in the Specimen
- What is being tested?
- EndoScell™ intraoperative handheld microscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
- Being tested
- EndoScell™ intraoperative handheld microscope
- Keywords
- Breast-Conserving Surgery, Breast Cancer, Margins, microscope
- Medical subject headings
- Breast Neoplasms, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoScell™ intraoperative handheld microscopeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ES group | Experimental | All enrolled patients underwent breast-conserving surgery with standard-of-care frozen-section margin assessment. The direction-specific margin specimens were additionally imaged ex vivo with EndoSCell Receives: Device: EndoScell™ intraoperative handheld microscope |
| FS group | Other | All enrolled patients underwent breast-conserving surgery. Each direction-specific margin specimen was imaged ex vivo with EndoSCell after topical staining, and the same tissue surface was then processed for standard-of-care frozen-section and permanent histopathology. Receives: Device: EndoScell™ intraoperative handheld microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 7 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Jul 2025
- Primary completion30 Apr 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast-Conserving SurgeryStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoqing Fan, MD, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029646
- Sponsor's protocol ID
- BC-P37
- Status last verified
- Sep 2025
- First submitted
- 11 Jun 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Research on the Accuracy of Margin Interpretation in Breast-Conserving Surgery for Breast Cancer: Cell Microscopic Imaging and Standard Frozen Pathology
- ClinicalTrials.gov ID
- NCT07029646
- Acronym / sponsor ID
- BC-P37
- Keywords
- Breast-Conserving Surgery, Breast Cancer, Margins, microscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ES group | Experimental | Device: EndoScell™ intraoperative handheld microscopeAll enrolled patients underwent breast-conserving surgery with standard-of-care frozen-section margin assessment. The direction-specific margin specimens were additionally imaged ex vivo with EndoSCell |
| FS group | Other | Device: EndoScell™ intraoperative handheld microscopeAll enrolled patients underwent breast-conserving surgery. Each direction-specific margin specimen was imaged ex vivo with EndoSCell after topical staining, and the same tissue surface was then processed for standard-of-care frozen-section and permanent histopathology. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoScell™ intraoperative handheld microscopeThe 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. | Device | ES group, FS group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoScell™ intraoperative handheld microscope in people with Breast-Conserving Surgery and Breast Carcinoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: Within 7 days after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.