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

NCT ID: NCT07131735

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-18
• Study Completion Date: 2025-09-18

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients who have undergone conservative breast cancer surgery

This group will undergo an analysis of gases emitted by cauterization. This intervention will not modify the duration of the surgery, nor will it alter the patient's treatment and prognosis. The gases will be analyzed through the detection device, which will not have direct contact with the patient and will not influence the surgical outcomes of the resection surgery. The patient will be followed for 2 years through their clinical care records in the UC Christus health network, looking for the occurrence of disease recurrence.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Clínico UC CHRISTUS

Santiago, Santiago Centro, Chile

Site Status: RECRUITING

Facultad de medicina UC

Santiago, Santiago Metropolitan, Chile

Site Status: ACTIVE_NOT_RECRUITING

Countries

Chile

Central Contacts

Maximiliano L Mariné

Role: CONTACT

maxmarine@uc.cl

+56952084996

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Other Identifiers

230719001

Identifier Type: -

Identifier Source: org_study_id