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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 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%
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Martini Ziekenhuis
Groningen, Provincie Groningen, Netherlands
UMC Utrecht
Utrecht, Utrecht, Netherlands
Start Date
January 12, 2026
Primary Completion Date
August 1, 2026
Completion Date
August 1, 2026
Last Updated
March 9, 2026
100
ESTIMATED participants
Lead Sponsor
SPCTR
Collaborators
NCT04704661
NCT04550494
Data Source & Attribution
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