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

NCT07352930 | Not Yet Recruiting

• 1 other identifier: KY2025-1339-01
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast-Conserving Surgery

Keywords

Intraoperative Imaging; Fluorescence-Guided Surgery; Positive Margins

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Reexcision rates

  From the date of secondary surgery until receipt of its final pathology report, assessed up to 60 days post-initial surgery.

• Mean Absolute Volume of Therapeutic Shave Tissue

  Intraoperative. Measured immediately after tissue excision

• Mean Proportion of Therapeutic Shave Volume to Total Resection Volume

  Intraoperative. Calculated after all tissue from the initial surgery is measured

• Patient-reported outcome /PRO

  90 ± 7 days post-initial surgery

• Record of Intraoperative Device Issues or Malfunctions

  Intraoperative. Recorded in real-time during device use.

Study Arms (2)

EndoSCell Scanner (ES Scanner)-Assisted Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

EndoSCell Scanner (ES Scanner) System DEVICE

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.

EndoSCell Scanner (ES Scanner)-Assisted Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Female, age ≥ 18 years.
• Scheduled to undergo breast-conserving surgery for the malignant breast lesion.
• Willing and able to comply with the study procedures and follow-up.
• Has provided written informed consent.

You may not qualify if:

• 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)
• ECOG performance status of 0 or 1.
• Pregnancy or lactation.
• Suspected pregnancy.
• 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.
• Unresolved adverse events from previous medications or diagnostic agents.
• 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.
• History of allergy to any oral or intravenous contrast agent.
• Uncontrolled comorbidities, including but not limited to:
• Active infection

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Margins of Excision

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Kun Wang

CONTACT

020-83827812; wangkun@gdph.org.cn

Liulu Zhang

CONTACT

020-83827812; zhangliulu@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)