Actively Recruiting

Age: 18Years +
All Genders
NCT07459062

Spectral Cancer Tissue Recognition - I

Led by SPCTR · Updated on 2026-03-09

100

Participants Needed

2

Research Sites

28 weeks

Total Duration

On this page

Sponsors

S

SPCTR

Lead Sponsor

U

UMC Utrecht

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Spectral Cancer Tissue Recognition - I

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Confirmed diagnosis of breast cancer requiring surgery
  • Planned for breast conserving surgery
Not Eligible

You will not qualify if you...

  • Undergoing breast amputation without confirmed cancer diagnosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Martini Ziekenhuis

Groningen, Provincie Groningen, Netherlands, 9728NT

Actively Recruiting

2

UMC Utrecht

Utrecht, Utrecht, Netherlands, 3584CX

Not Yet Recruiting

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Research Team

R

Robin Merjenburgh

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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