Spectral tissue recognition for detecting cancer at breast lumpectomy margins

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.