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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07459062

Acronym

SPCTR-I

Enrollment

100

Registered

2026-03-09

Start date

2026-01-12

Completion date

2026-08-01

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Margin Assessment

Brief 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%

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic performance of SPCTRone system to assess margin status of breast cancer specimens	Through study completion, an average of 6 months	Diagnostic performance indicators are: Sensitivity, Specificity, Negative Predictive Value, and Accuracy.

Countries

Netherlands

Contacts

CONTACTRobin Merjenburgh

robin@spctr.tech+31681119503

Outcome results