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

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.

NCT Number	NCT07131735
Lead Sponsor	Pontificia Universidad Catolica de Chile
Conditions	Breast Cancer
Enrollment	30 participants
Start Date	2023-12-18
Primary Completion	2025-09-18 (estimated)
Study Completion	2025-09-18 (estimated)
Updated on ClinicalTrials.gov	2025-08-20