Clinical trial · Observational
Assessment of Lumpectomy Margins With the Histolog Scanner in Comparison With Intraoperative Imaging Techniques
Imaging of Lumpectomy Surface With Large Field-of-View Confocal Laser Scanning Microscope 'Histolog Scanner' for Breast Margin Assessment in Comparison With Intraoperative Imaging and Postoperative Histopathological Assessment
NCT05118568CI-TRIAL-00065570PolarhiscompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Study to assess the capability of using the Histolog Scanner, a recent large field-of-view confocal laser scanning medical imaging device for the breast cancer detection in fresh lumpectomy margins.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Histolog Scanner | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Accuracy, Sensitivity, Specificity for breast cancer detection
- timeFrame
- Through study completion, an average of 6 months
- description
- Quantification of the performance achieved by breast surgeons and pathologists for breast cancer detection in Histolog Scanner images of lumpectomy margins
Secondary outcomes (1)
- measure
- Theoretical impact on re-operation rates
- timeFrame
- Through study completion, an average of 6 months
- description
- Extrapolation of the re-operation rate reduction based on positive-margin detection achieved with the Histolog Scanner, in comparison with the local intraoperative margin assessment techniques.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult female patient ≥18 years old * Patient Scheduled for breast conserving surgery of invasive and/ or in situ ductal carcinoma (DCIS). * Patient able to read, understand and give informed consent Exclusion Criteria: * Patient previously treated for ipsilateral breast cancer surgery * Patient with previous radiotherapy of the breast * Patient with multicentric breast cancer * Patients with planed mastectomy, tumor-adapted breast reduction * Patient with presurgical neo-adjuvant treatment * Patient is pregnant/lactating * Participation in any other clinical study that would affect data acquisition
References
Publications (0)
Data not yet available
No reference posted for this study.