NCT07111728 Intraoperative Margin Assessment in Breast Cancer With HSI-Raman
| NCT ID | NCT07111728 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 104 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 104 participants in total. It began in 2025-10-06 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Carlo F Morasso, Ph.D.
PRINCIPAL INVESTIGATOR
Istituti Clinici Scientifici Maugeri
Frequently Asked Questions
Who can join the NCT07111728 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 85 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07111728 currently recruiting?
Yes, NCT07111728 is actively recruiting participants. Contact the research team at fabio.corsi@icsmaugeri.it for enrollment information.
Where is the NCT07111728 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT07111728 clinical trial?
NCT07111728 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The principal investigator is Carlo F Morasso, Ph.D. at Istituti Clinici Scientifici Maugeri. The trial plans to enroll 104 participants.
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