A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Cancer: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- The rate of positive margins on final pathological testing
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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.
研究组 & 干预措施
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.
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.
干预措施: EndoSCell Scanner (ES Scanner) System (Device)
结局指标
主要结局
The rate of positive margins on final pathological testing
时间窗: 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.
次要结局
- 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)
- Record of Intraoperative Device Issues or Malfunctions(Intraoperative. Recorded in real-time during device use.)
- Patient-reported outcome /PRO(90 ± 7 days post-initial surgery)
研究者
Kun Wang
Clinical Professor
Guangdong Provincial People's Hospital