Intraoperative margin checking with hyperspectral imaging and Raman spectroscopy for lumpectomy
Official title: Multimodal Hyperspectral Imaging and Raman Spectroscopy for Intraoperative Assessment of Breast Tumor Resection Margins
Run by Istituti Clinici Scientifici Maugeri SpA · NCT07111728 · Data updated 2026-11-12
This study will test a device that scans removed breast tissue during lumpectomy to quickly flag spots where cancer might remain at the edges in women with invasive breast cancer or DCIS.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | Women only |
| Enrollment | 104 (estimated) |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia, Lombardy) |
| Status | Recruiting |
| Started | October 6, 2025 |
| Main results expected | October 2028 |
| Study ends | December 2028 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07111728 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women with histologically confirmed ductal carcinoma in situ (DCIS) or invasive breast carcinoma on preoperative core biopsy who are scheduled for breast-conserving surgery and can give informed consent are ideal candidates.
✕Probably not a fit
Patients with benign preoperative diagnoses, advanced (stage III/IV) or metastatic disease, those planned for neoadjuvant chemotherapy or mastectomy, pregnant or breastfeeding women, or those unable to consent are unlikely to benefit from this device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-arm diagnostic study will use the Spectra-BREAST system, which combines hyperspectral imaging and Raman spectroscopy with AI, to scan the entire surface of freshly excised lumpectomy specimens. Algorithms will be trained on an initial set of up to 74 specimens with known pathology, then the fully integrated device will be applied to a separate validation cohort as surgeons perform breast-conserving surgery. The device's real-time flags will be compared to standard pathology of specimen margins to determine accuracy in identifying cancer at the edges. If accurate, the approach could be used intraoperatively to guide immediate additional tissue removal.
Why it matters
Potential benefit: If successful, the device could lower the chance of needing a second operation by identifying positive margins during the initial surgery.
How similar studies have gone: Related optical and spectroscopic margin-detection approaches (HSI or Raman) have shown promising pilot results, but combining HSI and Raman with AI for intraoperative margin detection remains largely experimental and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, Lombardy, Italy Recruiting
Study contacts
- Principal investigator: Carlo F Morasso, Ph.D. — Istituti Clinici Scientifici Maugeri
- Study coordinator: Fabio Corsi, Prof.
- Email: fabio.corsi@icsmaugeri.it
- Phone: +390382592219
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.