Intraoperative fluorescence system to guide lumpectomy in breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the EndoSCell Scanner, a fluorescence-guided system used during breast-conserving surgery to detect residual cancer and reduce the need for additional surgeries. Researchers compare outcomes with this device to standard practice without it to determine its accuracy and potential to lower positive margins. Eligible participants are women with primary breast cancer scheduled for lumpectomy, who will undergo cavity scanning after tumor removal. The study examines whether the device improves margin status and how reliably it detects cancer in the surgical cavity walls.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Kun Wang
• Email: wangkun@gdph.org.cn
• Phone: 020-83827812

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.