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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorPontificia Universidad Catolica de Chile

About this trial

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.

Eligibility criteria

Qualifiers

Histologically confirmed diagnosis of malignant breast cancer

Scheduled for BCS at the Hospital UC

Able and willing to provide informed consent

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

30 Participants
are grouped into 1 trial group