Spectral Cancer Tissue Recognition - I

This analytical performance study aims to validate the SPCTRone system for use in breast conserving surgery of breast cancer patients. By collecting spectral biomarkers and correlating these with the golden standard of histopathological assessment by a pathologist, we aim to train and optimize an AI model that is able to achieve the following outcomes with classifying tissues: * Sensitivity (percentage of classified positive margins of actual positive margins): ≥ 96% CI 95.5-97.5% * Specificity (percentage of classified free margins of actual free margins): 96% CI 95.5-97.5% * Accuracy (total correctly classified margins): ≥ 96% CI 95.5-97.5% * Negative predictive value (amount of true negative - free margins - among the classified negative margins): ≥ 95% CI 94.5-96.5%

NCT Number	NCT07459062
Lead Sponsor	SPCTR Collaborators: UMC Utrecht, Martini Hospital Groningen
Conditions	Margin Assessment, Breast Cancer
Enrollment	100 participants
Start Date	2026-01-12
Primary Completion	2026-08-01 (estimated)
Study Completion	2026-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-09