NCT07459062

Spectral Cancer Tissue Recognition - I

Explorative, Multi-centre, Prospective, Observational Study Evaluating the Feasibility of the SPCTR Prototype for Margin Assessment During Breast Conserving Surgery in Breast Cancer Patients.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: SPCTR · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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%

Conditions

• Margin Assessment
• Breast Cancer

Timeline

• Start date: 2026-01-12
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

2 sites across 1 country: Netherlands