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NCT Number: NCT07459062

Spectral Cancer Tissue Recognition - I

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%

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Key information

Conditions

Margin Assessment Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Martini Ziekenhuis, Groningen, Provincie Groningen, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic performance of SPCTRone system to assess margin status of breast cancer specimens

    Time frame: Through study completion, an average of 6 months

    Diagnostic performance indicators are: Sensitivity, Specificity, Negative Predictive Value, and Accuracy.

Study contacts

Contact information is provided by the study sponsor or research team.

Robin Merjenburgh

CONTACT

[email protected]

+31681119503

Sponsors and collaborators

Lead sponsor

SPCTR

Industry

Collaborators

  • Martini Hospital Groningen
  • UMC Utrecht

Registry information

Official study title

Explorative, Multi-centre, Prospective, Observational Study Evaluating the Feasibility of the SPCTR Prototype for Margin Assessment During Breast Conserving Surgery in Breast Cancer Patients.

Acronym: SPCTR-I

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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