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Spectral Cancer Tissue Recognition - I

RECRUITINGSponsored by SPCTR
Actively Recruiting
SponsorSPCTR
Started2026-01-12
Est. completion2026-08-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07459062

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%

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

Breast CancerCancerMargin Assessment

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