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.
Histologically confirmed diagnosis of malignant breast cancer
Scheduled for BCS at the Hospital UC
Able and willing to provide informed consent
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
The study will recruit women from all over Chile who are indicated for conservative breast cancer surgery. It is estimated that the majority of patients will be those from Santiago de Chile who receive care from professionals in the UC Christus Health Network and decide to have surgery at the UC CHRISTUS Clinical Hospital.
Other
Prospective
Not listed
Differentiation of cancerous tissue from normal tissue
Specificity, sensitivity, and accuracy of the device and software in tissue classification
Applicability to the surgical workflow
Installation time and the surgeon's subjective assessment will be measured using the "Device Applicability to Surgical Workflow" survey, which comprises three questions for a total score of 3-15 points. The survey will be administered once to each surgeon.
Biocompatibility
Biocompatibility of the materials used will be assessed by documenting adverse reactions during the surgical procedure and the immediate postoperative period.
Detecting volatile organic compounds in breast cancer tissue.
The device is capable of real-time detection of organic compounds, with a latency not exceeding 1.5 seconds, and exhibits variable response slopes depending on the specific volatile organic compounds to which it is exposed.
Complications associated with the use of the device
Late complications related to device use will be assessed through reported occurrences.
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