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NCT Number: NCT07111728

Intraoperative Margin Assessment in Breast Cancer With HSI-Raman

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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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, Lombardy, 27100, Italy

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. 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).

    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 outcomes

  1. Concordance of HSI-only versus combined HSI + RS predictions

    Time frame: 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.

  2. Time from specimen removal to Spectra-BREAST system result

    Time frame: Per specimen, measured intraoperatively

    Time (in minutes) from excision of the lumpectomy specimen to presentation of the Spectra-BREAST margin results.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabio Corsi, Prof.

CONTACT

[email protected]

+390382592219

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study title

Multimodal Hyperspectral Imaging and Raman Spectroscopy for Intraoperative Assessment of Breast Tumor Resection Margins

Acronym: Spectra-BREAST

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 8, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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