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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed diagnosis of malignant breast cancer

• Scheduled for BCS at the Hospital UC

• Able and willing to provide informed consent

Locations
Other Locations
Chile
Facultad de medicina UC
ACTIVE_NOT_RECRUITING
Santiago
Hospital Clínico UC CHRISTUS
RECRUITING
Santiago
Contact Information
Primary
Maximiliano L Mariné
maxmarine@uc.cl
+56952084996
Time Frame
Start Date: 2023-12-18
Estimated Completion Date: 2025-09-18
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Pontificia Universidad Catolica de Chile

This content was sourced from clinicaltrials.gov