Intraoperative Margin Assessment in Breast Cancer With HSI-Raman (Spectra-BREAST)

Istituti Clinici Scientifici Maugeri SpA

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Diagnostic Test: Spectra-BREAST system in DCIS Breast Cancer; Diagnostic Test: Spectra-BREAST system in Invasive Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07111728

0012251/25

Details and patient eligibility

About

Breast-conserving surgery (lumpectomy) aims to remove cancer while preserving healthy tissue, but up to 20% of patients require a second operation because cancer cells remain at the edge (margin) of the removed tissue. The Spectra-BREAST study evaluates a new optical device that combines hyperspectral imaging (HIS) and Raman spectroscopy (RS) with artificial-intelligence analysis to quickly assess the entire surface of excised breast specimens during surgery. By flagging areas at risk of positive margins in real time, the device may help surgeons remove any remaining cancer in a single procedure.

In this prospective, single-arm diagnostic study, surgeons will use the Spectra-BREAST system on freshly resected breast tissue from up to 99 women undergoing lumpectomy for invasive carcinoma or ductal carcinoma in situ. First, the device's cancer-detection algorithms will be trained on 74 specimens with known pathology. Then, in a separate group of patients, the fully integrated device will be tested on all six faces of each lumpectomy specimen and its predictions will be compared against the gold-standard histopathology margin assessment. Key measures include the sensitivity and specificity of the device's margin predictions, the time needed to generate results, and the device's usability in a clinical setting.

Enrollment: 104 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Histologically confirmed diagnosis of ductal carcinoma in situ (B5a) or invasive breast carcinoma (B5b) on pre-operative core needle biopsy

Scheduled to undergo breast-conserving surgery (lumpectomy)

Able and willing to provide written informed consent

Exclusion criteria

Pre-operative histologic or cytologic diagnosis of a benign breast lesion (B2/C2)

Initial diagnosis of advanced (stage III/IV) or metastatic breast carcinoma, or indication for neoadjuvant chemotherapy

Neurocognitive disorders that would impair comprehension of the study procedures or consent process

Concurrent pregnancy or breastfeeding

Trial design

104 participants in 2 patient groups

DCIS breast cancer

Treatment:

Diagnostic Test: Spectra-BREAST system in DCIS Breast Cancer

Invasive Breast Cancer

Treatment:

Diagnostic Test: Spectra-BREAST system in Invasive Breast Cancer