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NCT Number: NCT07352930

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

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.

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Key information

Conditions

Breast-conserving Surgery Margins of Excision Morphological and Microscopic Findings Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Dr. Zhang, MD

CONTACT

[email protected]

020-83827812-80420

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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.

    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.

  2. Mean Absolute Volume of Therapeutic Shave Tissue

    Time frame: Intraoperative. Measured immediately after tissue excision

    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.

  3. Mean Proportion of Therapeutic Shave Volume to Total Resection Volume

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

    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%.

  4. Patient-reported outcome /PRO

    Time frame: 90 ± 7 days post-initial surgery

    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.

  5. Record of Intraoperative Device Issues or Malfunctions

    Time frame: Intraoperative. Recorded in real-time during device use.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kun Wang

CONTACT

[email protected]

020-83827812

Liulu Zhang

CONTACT

[email protected]

020-83827812

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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