Intraoperative Detection of Breast Cancer by Electrosurgical Gas Analysis and Artificial Intelligence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Differentiation of cancerous tissue from normal tissue
研究概览
简要总结
The aim of this clinical trial is to assess the feasibility of training a device capable of distinguishing various gases emitted by tissues cauterized by an electrosurgical unit during a breast cancer resection surgery. The patients to be enrolled will be women over 18 years old diagnosed with breast cancer who are indicated for conservative breast cancer resection surgery as treatment.
The main questions to be answered are:
The specificity and sensitivity of the device in detecting margins compromised with tumor cells in resection surgeries.
Evaluate the applicability of the device in breast cancer surgeries for real-time detection of margins.
Evaluate the differences in the pattern of gases emitted in tumor cells vs normal cells.
By consenting, the study patients will allow the investigative team to access the clinical record, results of images, post-surgical biopsies, recording of the surgery while preserving the patient's anonymity, and the installation of the gas detection device. This device does not alter the flow of the surgery and does not add additional risk to it.
详细描述
The study will consist of measuring gases emitted during surgery. Prior to this, the device will be trained in the detection and recognition of the most prevalent gases in cancerous tissue. This will enable the AI to detect and classify cancerous breast tissue from healthy tissue. The study will include patients with different types and subtypes of breast cancer, such as ductal carcinoma in situ invasive ductal carcinoma, invasive lobular carcinoma, triple-negative breast cancer, human epidermal growth factor receptor 2 positive breast cancer, and hormone receptor-positive breast cancer. These types and subtypes reflect the diversity and complexity of breast cancer and may influence the performance and accuracy of the BCGC device.
During the clinical testing phase, the laboratory-acquired tissue detection capability will be evaluated in a real situation. For this, the device will be connected to a sterile PVC hose directly connected to a smoke extractor associated with the electrosurgical unit that will cauterize the tissues. To evaluate the sensitivity, specificity, and accuracy of the device, the AI's detection will be compared with the quick biopsy and the deferred biopsy of the surgical piece. For this, access will be obtained to the histological reports and the surgery will be recorded to identify margins.
The device will be calibrated once a month with gases of known nature, a maximum variability of 5% will be tolerated. If a greater variability is detected at the time of calibration, it will be changed to every 2 weeks. The information will be anonymized and stored on an SSD unit and will be deleted 5 years after the completion of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Histologically confirmed diagnosis of malignant breast cancer
- •Scheduled for BCS at the Hospital UC
- •Able and willing to provide informed consent
排除标准
- •Pregnant or lactating women
- •Patients with known hypersensitivity or allergy to any component of the BCGC device
- •Participation in another interventional clinical trial within 30 days prior to enrolment
结局指标
主要结局
Differentiation of cancerous tissue from normal tissue
时间窗: Evaluation will be conducted 2 months post-surgery, comparing the biopsy results with the classification made by the device.
Specificity, sensitivity, and accuracy of the device and software in tissue classification
次要结局
- Applicability to the surgical workflow(The survey will be done 30 minutes after the conclusion of surgery and is estimated to require two minutes to complete.)
- Biocompatibility(Adverse reactions will be evaluated from the moment of intervention up to 48 hours after the surgical procedure)
- Detecting volatile organic compounds in breast cancer tissue.(Measurement will occur intraoperatively from the surgeon's first electrosurgical incision until removal of the primary specimen-typically within the first hour of surgery. This timeframe applies to every analyzed procedure.)
- Complications associated with the use of the device(Complications associated with device use will be assessed during the late postoperative period, defined as 48 hours after surgery up to one month post-intervention.)