Intraoperative Margin Assessment in Breast Cancer With HSI-Raman

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT07111728
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-07-28
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Study Start: 2025-12-01
• Primary Completion: 2028-10
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 104

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of Spectra-BREAST system margin status prediction	Within 21 days after surgery (latest expected receipt of the final pathology report).	Proportion of resection faces correctly classified by the Spectra-BREAST device as "positive margin" or "negative margin" when compared to gold-standard postoperative histopathology. Sensitivity and specificity will both be calculated independently in Invasive Breast Cancer and in DCIS breast cancer across all specimens in the validation cohort.

Secondary Outcome Measures

Name	Time	Method
Concordance of HSI-only versus combined HSI + RS predictions	During Spectra-BREAST procedure	Percentage agreement between margin classifications made using hyperspectral imaging alone and those made by the integrated HSI + Raman spectroscopy algorithm, relative to histopathology results.
Time from specimen removal to Spectra-BREAST system result	Per specimen, measured intraoperatively	Time (in minutes) from excision of the lumpectomy specimen to presentation of the Spectra-BREAST margin results.

Trial Locations

Locations (1)

Istituti Clinici Scientifici Maugeri IRCCS; 🇮🇹 Pavia, Lombardy, Italy