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Spectral Cancer Tissue Recognition - I

NCT07459062 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-03-09

No results posted yet for this study

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

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • Martini Hospital Groningen

    collaborator OTHER

  • SPCTR

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-12
Primary Completion
2026-08-01
Completion
2026-08-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07459062 on ClinicalTrials.gov