Intraoperative Detection of Breast Cancer by Electrosurgical Gas Analysis and Artificial Intelligence

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT07131735
• Lead Sponsor: Pontificia Universidad Catolica de Chile

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-12-18
• Status Verified: 2025-07
• Study First Submitted: 2025-07-28
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Primary Completion: 2025-09-18
• Study Completion: 2025-09-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Histologically confirmed diagnosis of malignant breast cancer
• Scheduled for BCS at the Hospital UC
• Able and willing to provide informed consent

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differentiation of cancerous tissue from normal tissue	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

Secondary Outcome Measures

Name	Time	Method
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.	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	Adverse reactions will be evaluated from the moment of intervention up to 48 hours after the surgical procedure	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.	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.	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	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.	Late complications related to device use will be assessed through reported occurrences.

Trial Locations

Locations (2)

Facultad de medicina UC; 🇨🇱 Santiago, Región Metropolitana, Chile

Hospital Clínico UC CHRISTUS; 🇨🇱 Santiago, Santiago centro, Chile