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

Official title

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

Overview

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.

Interventions

• 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 f

Primary outcome measures

• The rate of positive margins on final pathological testing [Time frame: 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 (5)

• Reexcision rates [Time frame: 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 [Time frame: Intraoperative. Measured immediately after tissue excision]
• Mean Proportion of Therapeutic Shave Volume to Total Resection Volume [Time frame: Intraoperative. Calculated after all tissue from the initial surgery is measured]
• Patient-reported outcome /PRO [Time frame: 90 ± 7 days post-initial surgery]
• Record of Intraoperative Device Issues or Malfunctions [Time frame: Intraoperative. Recorded in real-time during device use.]

Eligibility criteria

Inclusion criteria

• 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.
• No other uncontrolled serious medical conditions aside from the cancer diagnosis (see Exclusion Criteria for details).
• 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.

Exclusion criteria

• 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
• 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.
• Any condition where, in the investigator's judgment, participation would not be in the best interest of the participant.
• Planned re-excision lumpectomy due to positive margins from a prior surgery performed before enrollment.
• Prior surgical history in the ipsilateral breast, including breast cancer surgery, mastectomy, breast reconstruction, or implant placement.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Diagnostic

Study locations

China · 1 center

• Guangdong Provincial People's Hospital — Guangzhou

Identifiers

NCT: NCT07352930 · KY2025-1339-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗