Breast CancerSpectra-BREASTNCT07111728
Intraoperative Margin Assessment in Breast Cancer With HSI-Raman
An observational study of Breast Cancer, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Spectra-BREAST system in Invasive Breast Cancer and Spectra-BREAST system in DCIS Breast Cancer
- How many people
- 104 participants
- Where
- 1 siteItaly
- Study dates
- 6 Oct 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, Lombardy, 27100
About this study
Official title: Multimodal Hyperspectral Imaging and Raman Spectroscopy for Intraoperative Assessment of Breast Tumor Resection Margins
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
- Being tested
- Spectra-BREAST system in Invasive Breast Cancer, Spectra-BREAST system in DCIS Breast Cancer
- Keywords
- Breast-conserving surgery, Breast Cancer, Surgical margin assessment, Hyperspectral imaging, Raman spectroscopy, Optical spectroscopy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectra-BREAST system in Invasive Breast CancerDiagnostic 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 CancerDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| DCIS breast cancer | Not described Receives: Diagnostic Test: Spectra-BREAST system in DCIS Breast Cancer | |
| Invasive Breast Cancer | Not described Receives: Diagnostic Test: Spectra-BREAST system in Invasive Breast Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Percentage agreement between margin classifications made using hyperspectral imaging alone and those made by the integrated HSI + Raman spectroscopy algorithm, relative to histopathology results.
Measured: During Spectra-BREAST procedure
Time from specimen removal to Spectra-BREAST system result
Time (in minutes) from excision of the lumpectomy specimen to presentation of the Spectra-BREAST margin results.
Measured: Per specimen, measured intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start6 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Corsi, Istituti Clinici Scientifici Maugeri SpA
- Investigators
- Carlo F Morasso, Ph.D., Principal investigator, Istituti Clinici Scientifici Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111728
- Sponsor's protocol ID
- 0012251/25
- Acronym
- Spectra-BREAST
- Status last verified
- Mar 2026
- First submitted
- 28 Jul 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Hyperspectral Imaging and Raman Spectroscopy for Intraoperative Assessment of Breast Tumor Resection Margins
- ClinicalTrials.gov ID
- NCT07111728
- Acronym / sponsor ID
- Spectra-BREAST / 0012251/25
- Conditions
- Breast Cancer
- Keywords
- Breast-conserving surgery, Breast Cancer, Surgical margin assessment, Hyperspectral imaging, Raman spectroscopy, Optical spectroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCIS breast cancer | – | Diagnostic Test: Spectra-BREAST system in DCIS Breast Cancer |
| Invasive Breast Cancer | – | Diagnostic Test: Spectra-BREAST system in Invasive Breast Cancer |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectra-BREAST system in Invasive Breast CancerParticipants' 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. | Diagnostic test | Invasive Breast Cancer |
| Spectra-BREAST system in DCIS Breast CancerParticipants' 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 | Diagnostic test | DCIS breast cancer |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Official webpage of the Spectra-BREAST projectLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlo F Morasso, Ph.D. principal investigator
Istituti Clinici Scientifici Maugeri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Corsi, Prof. (+390382592219, fabio.corsi@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.