Intraoperative Margin Assessment in Breast Cancer With HSI-Raman
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spectra-BREAST system in Invasive Breast Cancer, Spectra-BREAST system in DCIS Breast Cancer.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 85 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multimodal Hyperspectral Imaging and Raman Spectroscopy for Intraoperative Assessment of Breast Tumor Resection Margins
Overview
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.
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): - 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
Primary outcome measures
- Sensitivity and specificity of Spectra-BREAST system margin status prediction [Time frame: Within 21 days after surgery (latest expected receipt of the final pathology report).]
Secondary outcome measures (2)
- Concordance of HSI-only versus combined HSI + RS predictions [Time frame: During Spectra-BREAST procedure]
- Time from specimen removal to Spectra-BREAST system result [Time frame: Per specimen, measured intraoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Istituti Clinici Scientifici Maugeri IRCCS — Pavia
Identifiers
NCT: NCT07111728 · 0012251/25