RecruitingNCT07459062

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.


Sponsor

SPCTR

Enrollment

100 participants

Start Date

Jan 12, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new imaging technology called spectral tissue recognition—which analyzes light reflected from tissue during surgery to distinguish cancer from healthy tissue in real time—to help surgeons remove breast cancer more precisely during breast-conserving surgery (lumpectomy). **You may be eligible if...** - You are 18 or older - You have been diagnosed with breast cancer and require surgical removal - You are scheduled for a breast-conserving operation (lumpectomy rather than full mastectomy) **You may NOT be eligible if...** - You are undergoing breast removal (mastectomy) without a confirmed cancer diagnosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Martini Ziekenhuis

Groningen, Provincie Groningen, Netherlands

UMC Utrecht

Utrecht, Utrecht, Netherlands

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NCT07459062


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