Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Margin Assessment | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Breadloaf slices
- description
- Only sliced specimen are scanned during phase 1
- label
- Whole specimen & Breadloaf slices
- description
- Whole specimen and sliced specimen are scanned during phase 2
Primary outcomes (1)
- measure
- Diagnostic performance of SPCTRone system to assess margin status of breast cancer specimens
- timeFrame
- Through study completion, an average of 6 months
- description
- Diagnostic performance indicators are: Sensitivity, Specificity, Negative Predictive Value, and Accuracy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available