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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCIS breast cancer |
| ||
| Invasive Breast Cancer |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance of HSI-only versus combined HSI + RS predictions | Percentage agreement between margin classifications made using hyperspectral imaging alone and those made by the integrated HSI + Raman spectroscopy algorithm, relative to histopathology results. | During Spectra-BREAST procedure |
| Time from specimen removal to Spectra-BREAST system result |
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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
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabio Corsi, Prof. | Contact | +390382592219 | fabio.corsi@icsmaugeri.it |
| Name | Affiliation | Role |
|---|---|---|
| Carlo F Morasso, Ph.D. | Istituti Clinici Scientifici Maugeri | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituti Clinici Scientifici Maugeri IRCCS | Recruiting | Pavia | Lombardy | 27100 | Italy |
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| Label | URL |
|---|---|
| Official webpage of the Spectra-BREAST project | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| 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 |
|
Time (in minutes) from excision of the lumpectomy specimen to presentation of the Spectra-BREAST margin results. |
| Per specimen, measured intraoperatively |
| D017437 |
| Skin and Connective Tissue Diseases |