Breast Cancer Early Stage Breast Cancer (Stage 1-3)FLASHNCT07311317
Cellular-Level Fluorescence Imaging for Intraoperative Margin Assessment in Breast Cancer
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by West China Hospital at 3 sites in China.
Trial summary
Accurate intraoperative margin assessment in breast cancer surgery remains challenging. Current reliance on frozen section pathology is limited by prolonged processing time, sampling constraints, and resource intensity, contributing to variable outcomes. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- How many people
- 165 participants
- Where
- 3 sitesChina
- Study dates
- Jan 2026to Jan 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll 165 adult female patients scheduled to undergo breast surgery for histologically confirmed breast cancer. Eligible participants must provide written informed consent.
Who may be able to join
- Age between 18 - 70 years
- Patients scheduled for breast tumor resection
- Clinically or radiologically showing a solitary lesion and
- (Before neoadjuvant chemotherapy) Maximum tumor diameter ≤ 5cm;
- cN0-1;
- No clinical or imaging evidence of nipple, skin, chest wall invasion, or distant metastasis before surgery.
- Subjects voluntarily sign informed consent or are exempted from signing upon approval by the ethics committee.
Who cannot join
- Inflammatory breast cancer;
- Patients allergic to methylene blue and sodium fluorescein;
- Unable to understand the trial requirements or unable to complete the study follow-up plan;
- Pregnant and breastfeeding women;
- Patients unable to complete follow-up due to mental illness, cognitive or emotional disorders;
- Those with severe comorbidities (such as organ dysfunction, immune deficiency) or poor general condition;
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- Those participating in other clinical studies that may affect this trial;
- Those for whom satisfactory specimens for both frozen pathology and paraffin pathology cannot be obtained during surgery;
- Those who cannot obtain a paraffin pathology report.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
the Fourth People'S Hospital of Sichuan Province
Chengdu
donglin zhang, +86 13684050025
West China Fourth Hospital, Sichuan University
Chengdu
bin ma, +86 13999878091
West China Hospital
Chengdu
zhenggui Du, docduzg@163.com
About this study
Official title: Assessment of the Accuracy of a Novel Cellular-Level Fluorescence-Guided Imaging Technique in Scanning Tumor Margins During Breast Tumor Resection: A Prospective, Self-Controlled Study
Accurate intraoperative margin assessment in breast cancer surgery remains challenging. Current reliance on frozen section pathology is limited by prolonged processing time, sampling constraints, and resource intensity, contributing to variable outcomes.
The EndoSCell Scanner is a novel cellular-resolution fluorescence-guided imaging technology designed to address these limitations. It enables real-time, pathology-level visualization of malignant cellular features at the surgical bed. With a 3mm probe allowing comprehensive 360° margin assessment, it reduces procedural time to under five minutes and may significantly lower secondary surgery rates.
This prospective, self-controlled study aims to evaluate the accuracy of the EndoSCell Scanner for intraoperative margin assessment in patients undergoing mastectomy. Its performance will be systematically compared against both frozen section and final paraffin pathology to validate sensitivity and operational efficiency. If proven effective, this technology could become a standard adjunct tool, standardizing precision in breast cancer surgery and improving patient outcomes by enhancing surgical consistency.
Read the detailed description
This study is a multicenter, prospective, self-controlled study. Basis for Sample Size Calculation: According to the results of the first phase, the accuracy of frozen pathology is 98.2%. Assuming that the detection interpretation results of ES are not inferior to intraoperative frozen pathology, a one-sided test will be conducted, with α=0.02, 1-β=0.8, and the non-inferiority margin is 0.02. The estimated required sample size is 593. Considering a 10% exclusion rate, the total sample size will be 659. Each patient is expected to have at least 4 samples taken, totaling 165 patients.
Data Collection:1)Basic patient information: age, gender; 2)Tumor diagnosis (including imaging diagnosis): location, size, and staging; 3)Intraoperative collected information: surgery start time, surgery end time; 4)Training and testing records of the physicians in the ES interpretation group; 5)Interpretation records: a.ES start time, ES interpretation end time, ES interpretation results, ES image satisfaction; b.Frozen pathology submission time, report receipt time, report results; c.Paraffin pathology submission time, report time, and report results.
The statistical analysis will be performed using SAS statistical software, version 9.4 or higher. All statistical tests will be two-sided. A P value less than or equal to 0.05 will be considered statistically significant. The description of quantitative indicators will include the mean, standard deviation, median, minimum, maximum, and interquartile range. The description of categorical indicators will use the number and percentage of each category. The comparison of general conditions between the two groups will be analyzed using appropriate methods based on the type of indicators. The consistency evaluation of quantitative data will use the Bland-Altman method and ICC.
- Keywords
- Breast Cancer,, Fluorescence-guided, Cellular
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the sensitivity and specificity of the EndoSCell Scanner (ES) detection, using paraffin pathology as the gold standard, in comparison to rapid frozen section (FS) pathology.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fourth People's Hospital of Sichuan Province
- Responsible party
- Principal investigator, Du Zhenggui, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311317
- Sponsor's protocol ID
- 2025-1955
- Acronym
- FLASH
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Accuracy of a Novel Cellular-Level Fluorescence-Guided Imaging Technique in Scanning Tumor Margins During Breast Tumor Resection: A Prospective, Self-Controlled Study
- ClinicalTrials.gov ID
- NCT07311317
- Acronym / sponsor ID
- FLASH / 2025-1955
- Keywords
- Breast Cancer,, Fluorescence-guided, Cellular
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- Fourth People's Hospital of Sichuan Province
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 Dec 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.
Accurate intraoperative margin assessment in breast cancer surgery remains challenging. Current reliance on frozen section pathology is limited by prolonged processing time, sampling constraints, and resource intensity, contributing to variable outcomes.
The EndoSCell Scanner is a novel cellular-resolution fluorescence-guided imaging technology designed to address these limitations. It enables real-time, pathology-level visualization of malignant cellular features at the surgical bed. With a 3mm probe allowing comprehensive 360° margin assessment, it reduces procedural time to under five minutes and may significantly lower secondary surgery rates.
This prospective, self-controlled study aims to evaluate the accuracy of the EndoSCell Scanner for intraoperative margin assessment in patients undergoing mastectomy. Its performance will be systematically compared against both frozen section and final paraffin pathology to validate sensitivity and operational efficiency. If proven effective, this technology could become a standard adjunct tool, standardizing precision in breast cancer surgery and improving patient outcomes by enhancing surgical consistency.
Detailed description
This study is a multicenter, prospective, self-controlled study. Basis for Sample Size Calculation: According to the results of the first phase, the accuracy of frozen pathology is 98.2%. Assuming that the detection interpretation results of ES are not inferior to intraoperative frozen pathology, a one-sided test will be conducted, with α=0.02, 1-β=0.8, and the non-inferiority margin is 0.02. The estimated required sample size is 593. Considering a 10% exclusion rate, the total sample size will be 659. Each patient is expected to have at least 4 samples taken, totaling 165 patients.
Data Collection:1)Basic patient information: age, gender; 2)Tumor diagnosis (including imaging diagnosis): location, size, and staging; 3)Intraoperative collected information: surgery start time, surgery end time; 4)Training and testing records of the physicians in the ES interpretation group; 5)Interpretation records: a.ES start time, ES interpretation end time, ES interpretation results, ES image satisfaction; b.Frozen pathology submission time, report receipt time, report results; c.Paraffin pathology submission time, report time, and report results.
The statistical analysis will be performed using SAS statistical software, version 9.4 or higher. All statistical tests will be two-sided. A P value less than or equal to 0.05 will be considered statistically significant. The description of quantitative indicators will include the mean, standard deviation, median, minimum, maximum, and interquartile range. The description of categorical indicators will use the number and percentage of each category. The comparison of general conditions between the two groups will be analyzed using appropriate methods based on the type of indicators. The consistency evaluation of quantitative data will use the Bland-Altman method and ICC.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll 165 adult female patients scheduled to undergo breast surgery for histologically confirmed breast cancer. Eligible participants must provide written informed consent.
Key inclusion criteria (7 listed)
- Age between 18 - 70 years
- Patients scheduled for breast tumor resection
- Clinically or radiologically showing a solitary lesion and
- Subjects voluntarily sign informed consent or are exempted from signing upon approval by the ethics committee.
Key exclusion criteria (9 listed)
- Inflammatory breast cancer;
- Patients allergic to methylene blue and sodium fluorescein;
- Unable to understand the trial requirements or unable to complete the study follow-up plan;
- Pregnant and breastfeeding women;
- Patients unable to complete follow-up due to mental illness, cognitive or emotional disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the sensitivity and specificity of the EndoSCell Scanner (ES) detection, using paraffin pathology as the gold standard, in comparison to rapid frozen section (FS) pathology.
Time frame: 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by West China Hospital at 3 sites 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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenggui DU (+86 13880768222, docduzg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the sensitivity and specificity of the EndoSCell Scanner (ES) detection, using paraffin pathology as the gold standard, in comparison to rapid frozen section (FS) pathology. (time frame: 3 month). 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 30 Dec 2025.