Intraoperative Margin Assessment in Breast Cancer With HSI-Raman

NCT07111728 | Recruiting

• 1 other identifier: 0012251/25
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast-conserving surgery; Breast Cancer; Surgical margin assessment; Hyperspectral imaging; Raman spectroscopy; Optical spectroscopy

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of Spectra-BREAST system margin status prediction

  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.

  Within 21 days after surgery (latest expected receipt of the final pathology report).

Secondary Outcomes (2)

• Concordance of HSI-only versus combined HSI + RS predictions

  During Spectra-BREAST procedure

• Time from specimen removal to Spectra-BREAST system result

  Per specimen, measured intraoperatively

Study Arms (2)

DCIS breast cancer

Diagnostic Test: Spectra-BREAST system in DCIS Breast Cancer

Invasive Breast Cancer

Diagnostic Test: Spectra-BREAST system in Invasive Breast Cancer

Interventions

Spectra-BREAST system in DCIS Breast Cancer DIAGNOSTIC_TEST

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

DCIS breast cancer

Spectra-BREAST system in Invasive Breast Cancer DIAGNOSTIC_TEST

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.

Invasive Breast Cancer

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All female patients referred consecutively to the Breast Unit at Istituti Clinici Scientifici Maugeri (IRCCS) in Pavia who present with an imaging-detected, clinically non-palpable breast lesion and are scheduled for breast-conserving surgery (lumpectomy).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, Lombardy, 27100, Italy

RECRUITING

Related Links

• Official webpage of the Spectra-BREAST project

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carlo F Morasso, Ph.D.

  Istituti Clinici Scientifici Maugeri

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Corsi, Prof.

CONTACT

+390382592219; fabio.corsi@icsmaugeri.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 8, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-03

Locations

IT (1)