Intraoperative Margin Assessment in Breast Cancer With HSI-Raman

Not yet recruitingOBSERVATIONAL
Enrollment

104

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

October 31, 2028

Study Completion Date

December 31, 2028

Conditions
Breast Cancer
Interventions
DIAGNOSTIC_TEST

Spectra-BREAST system in Invasive Breast Cancer

"Participants' excised breast lumpectomy specimens will be immediately imaged ex vivo using the investigational Spectra-BREAST system, a handheld optical device integrating two modalities~Hyperspectral imaging (HSI):~HSI captures reflectance spectra across 400-1400 nm over the entire specimen surface (up to 5 × 5 cm field of view). HIS provides spatial maps of tissue chemical composition and morphology to highlight regions suspicious for residual carcinoma.~Point-wise Raman spectroscopy (RS):~RS will allow to acquire high-resolution molecular fingerprints both at high and low Raman shift on selected hotspots flagged by HSI as at risk. RS will be acquired on the surface of the specimens confirming the possible presence of positive margins~Spectra-BREAST system will allow to provide a near real time feedback to the surgeon on the presence and position of positive margins allowing a further resection if tissue if needed."

DIAGNOSTIC_TEST

Spectra-BREAST system in DCIS Breast Cancer

"Participants' excised breast lumpectomy specimens will be immediately imaged ex vivo using the investigational Spectra-BREAST system, a handheld optical device integrating two modalities Hyperspectral imaging (HSI): HSI captures reflectance spectra across 400-1400 nm over the entire specimen surface (up to 5 × 5 cm field of view). HIS provides spatial maps of tissue chemical composition and morphology to highlight regions suspicious for residual carcinoma. Point-wise Raman spectroscopy (RS): RS will allow to acquire high-resolution molecular fingerprints both at high and low Raman shift on selected hotspots flagged by HSI as at risk. RS will be acquired on the surface of the specimens and using a special needle probe 2 mm below the tissue surface thus confirming the possible presence of positive margins.~Spectra-BREAST system will allow to provide a near real time feedback to the surgeon on the presence and position of positive margins allowing a further resection if tissue if needed"

Trial Locations (1)

27100

Istituti Clinici Scientifici Maugeri IRCCS, Pavia

All Listed Sponsors
lead

Istituti Clinici Scientifici Maugeri SpA

OTHER