A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Cancer

A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Cancer: A Prospective Randomized Controlled Trial

The goal of this clinical trial is to learn if a novel intraoperative fluorescence-guided system (EndoSCell Scanner) can help surgeons more accurately remove all cancerous tissue during breast-conserving surgery in female patients aged 18 years or older, with primary breast cancer. The main questions it aims to answer are:

• Does the use of the EndoSCell Scanner system lower the rate of secondary surgeries needed due to positive cancer margins after the initial operation?
• How accurate is the EndoSCell Scanner system in detecting residual cancer cells on the walls of the surgical cavity during the operation?

Researchers will compare the surgical outcomes using the EndoSCell Scanner guidance to the expected outcomes from standard surgical practice without this technology to see if the system is effective.

Participants will:

• Receive their planned breast-conserving surgery (lumpectomy).
• Have their surgical cavity scanned with the EndoSCell Scanner device after the main tumor is removed.
• Have additional tissue removed from the cavity wall if the scanner indicates a potential cancer residue.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast-Conserving Surgery
• Intervention / Treatment: Device: EndoSCell Scanner (ES Scanner) System

• Study Type: Interventional
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kun Wang; Phone Number: 020-83827812; Email: wangkun@gdph.org.cn
• Study Contact Backup: Name: Liulu Zhang; Phone Number: 020-83827812; Email: zhangliulu@gdph.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital
      • Contact: Dr. Zhang, MD; Phone Number: 020-83827812-80420; Email: zhangliulu@gdph.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Pathologically confirmed diagnosis of primary invasive breast cancer, ductal carcinoma in situ (DCIS), or invasive breast cancer with a DCIS component. Acceptable diagnostic methods include core needle biopsy or fine-needle aspiration biopsy.
2. Female, age ≥ 18 years.
3. Scheduled to undergo breast-conserving surgery for the malignant breast lesion.
4. Willing and able to comply with the study procedures and follow-up.
5. Has provided written informed consent.
6. No other uncontrolled serious medical conditions aside from the cancer diagnosis (see Exclusion Criteria for details).

7. Adequate organ and bone marrow function, defined as:

   • White blood cell count > 3,000/μL
   • Platelet count > 75,000/μL
   • Total bilirubin ≤ institutional upper limit of normal (ULN)
   • AST (SGOT) / ALT (SGPT) < 2.5 × institutional ULN
   • Serum creatinine ≤ 1.5 mg/dL, OR creatinine clearance > 60 mL/min/1.73 m² (for participants with serum creatinine levels above institutional ULN)
8. ECOG performance status of 0 or 1.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Suspected pregnancy.
3. Prior injection of ICG or other fluorescent dyes for sentinel lymph node mapping on the day of surgery, before the planned lumpectomy cavity scan with the study device.
4. Unresolved adverse events from previous medications or diagnostic agents.
5. Uncontrolled hypertension, defined as persistent systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg. Patients with known hypertension must be stable on medication within these limits.
6. History of allergy to any oral or intravenous contrast agent.

7. Uncontrolled comorbidities, including but not limited to:

   • Active infection
   • Symptomatic congestive heart failure
   • Unstable angina pectoris
   • Cardiac arrhythmia
   • Hospitalization for COPD or asthma within the past 12 months
   • Psychiatric illness/social situations that would limit compliance with study requirements.
8. Any condition where, in the investigator's judgment, participation would not be in the best interest of the participant.
9. Planned re-excision lumpectomy due to positive margins from a prior surgery performed before enrollment.
10. Prior surgical history in the ipsilateral breast, including breast cancer surgery, mastectomy, breast reconstruction, or implant placement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EndoSCell Scanner (ES Scanner)-Assisted Intervention Group; The EndoSCell Scanner (ES Scanner) is an intraoperative fluorescence imaging system used during breast-conserving surgery to provide real-time, cellular-level visualization of the surgical cavity wall. During the surgery, after removing the main tumor specimen and the standard circumferential cavity shave margins, the cavity wall is locally stained with sodium fluorescein and methylene blue. Then, the ES Scanner probe is placed on the cavity wall tissue and the blue light is used to detect the fluorescence patterns related to residual cancer cells. The system processes and displays these images in real time, highlighting the areas that may contain residual cancer cells. This visual guidance aims to assist surgeons in precisely removing additional tissue margins ( "therapeutic shaves" ) from specific suspicious cavity wall locations during the initial surgery, in order to achieve a negative (no cancer) surgical margin in the first operation.	Device: EndoSCell Scanner (ES Scanner) System; The EndoSCell Scanner (ES Scanner) is an intraoperative fluorescence imaging system used during breast-conserving surgery to provide real-time, cellular-level visualization of the surgical cavity wall. During the surgery, after removing the main tumor specimen and the standard circumferential cavity shave margins, the cavity wall is locally stained with sodium fluorescein and methylene blue. Then, the ES Scanner probe is placed on the cavity wall tissue and the blue light is used to detect the fluorescence patterns related to residual cancer cells. The system processes and displays these images in real time, highlighting the areas that may contain residual cancer cells. This visual guidance aims to assist surgeons in precisely removing additional tissue margins ( "therapeutic shaves" ) from specific suspicious cavity wall locations during the initial surgery, in order to achieve a negative (no cancer) surgical margin in the first operation.
No Intervention: Control Group; Participants underwent standard breast-conserving surgery, which was completed after the resection of the main tumor specimen and the standard circumferential cavity shave margins. This group does not use the EndoSCell scanner system. Whether a second operation is needed depends on whether there is positive margins on final pathological testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of positive margins on final pathological testing	Positive margins were defined as tumor touching the edge of the specimen that was removed in patients with invasive cancer and tumor that was within 2 mm of the edge of the specimen removed in those with ductal carcinoma in situ.	From the date of the initial lumpectomy (Day 0) until the receipt of the final postoperative pathology report and surgical decision, assessed up to 30 days post-surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Absolute Volume of Therapeutic Shave Tissue	The average volume (in cubic centimeters, cc) of tissue excised as ES Scanner-guided Therapeutic Shaves (T-shaves) per participant. Volume calculation for each T-shave: length (cm) × width (cm) × depth (cm). The total T-shave volume per participant is the sum of all individual T-shave volumes. For participants who did not undergo T-shave excision, the volume is recorded as 0 cc.	Intraoperative. Measured immediately after tissue excision
Mean Proportion of Therapeutic Shave Volume to Total Resection Volume	The average percentage contribution of the T-shave volume to the total volume of all tissue resected during the initial surgery. Calculation: (T-shave volume) / (Main specimen volume + SOC shave volume + T-shave volume) × 100%.	Intraoperative. Calculated after all tissue from the initial surgery is measured
Record of Intraoperative Device Issues or Malfunctions	The frequency, type, and impact (e.g., on data acquisition, procedural continuity) of any device problems, technical failures, or operational difficulties encountered with the ES Scanner system during surgery.	Intraoperative. Recorded in real-time during device use.
Reexcision rates	defined as the proportion of patients who were returned to the operating room for further surgery for margin clearance. Although it was expected that surgeons would perform reexcision on patients whose final margin was positive, this decision was left to the surgeons' discretion.	From the date of secondary surgery until receipt of its final pathology report, assessed up to 60 days post-initial surgery.
Patient-reported outcome /PRO	The patients reported the postoperative cosmetic effect using the BREAST-Q Breast-Conserving Therapy Module. The scoring range of each sub-scale in this module (such as satisfaction, quality of life, etc.) is from 0 to 100 points, with a minimum of 0 and a maximum of 100. Higher scores always mean better results. A score of 100 represents the possible best state (such as the most satisfactory or the highest quality of life), while a score of 0 represents the possible worst state.	90 ± 7 days post-initial surgery

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Intraoperative Imaging; Fluorescence-Guided Surgery; Positive Margins
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings; Margins of Excision; Therapeutics; Drug Therapy; Drug Delivery Systems
• Other Study ID Numbers: KY2025-1339-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No