Spectral tissue recognition for detecting cancer at breast lumpectomy margins
Explorative, Multi-centre, Prospective, Observational Study Evaluating the Feasibility of the SPCTR Prototype for Margin Assessment During Breast Conserving Surgery in Breast Cancer Patients.
This project will test whether a handheld spectral device with AI can tell cancerous from healthy breast tissue during breast-conserving surgery in adults with confirmed breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Spctr Industry-sponsored |
| Locations | 2 sites (Groningen, Provincie Groningen and 1 other locations) |
| Trial ID | NCT07459062 on ClinicalTrials.gov |
What this trial studies
This observational analytical performance project collects spectral biomarkers from excised breast tissue during breast-conserving surgery and links those measurements to the gold standard of histopathology read by a pathologist. The collected spectra and matched pathology labels will be used to train and optimize an AI classification model to identify positive versus free surgical margins. The team aims for very high performance metrics (sensitivity, specificity, accuracy ≥96% and negative predictive value ≥95%) and will report confidence intervals for each metric. The work is conducted at two Dutch hospitals and does not change routine patient care beyond additional tissue measurements.
Who should consider this trial
Good fit: Adults (age ≥18) with a confirmed diagnosis of breast cancer who are scheduled for breast-conserving surgery at a participating center are ideal candidates.
Not a fit: People having mastectomy (breast removal) or those without a confirmed cancer diagnosis are not expected to benefit from this protocol.
Why it matters
Potential benefit: If successful, the device could help surgeons identify positive margins during lumpectomy and reduce the need for repeat surgeries.
How similar studies have performed: Related optical spectroscopy and AI approaches for margin detection have shown promising but variable results in pilot studies, so the approach is plausible but not yet standard of care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Confirmed diagnosis breast cancer for which surgical procedure is needed * Planned for breast conserving surgery Exclusion Criteria: * Person that undergoes breast amputation without confirmed cancer diagnosis
Where this trial is running
Groningen, Provincie Groningen and 1 other locations
- Martini Ziekenhuis — Groningen, Provincie Groningen, Netherlands (Recruiting)
- UMC Utrecht — Utrecht, Utrecht, Netherlands (Not_yet_recruiting)
Study contacts
- Study coordinator: Robin Merjenburgh
- Email: robin@spctr.tech
- Phone: +31681119503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.