Clinical trial · Interventional
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment in a Single-centric PMPF Study (SHIELD)
NCT05946759CI-TRIAL-00075299SHIELDcompletedN/AClinicalTrials.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)
This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.
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 - Ductal Carcinoma in Situ (DCIS) | Breast Ductal Carcinoma In Situ | ALIAS | 0.85 |
| Breast-Conserving Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Histolog Scanner | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Prospective
- description
- 50 prospective subjects
- interventionNames
- Device: Histolog Scanner
- type
- NO_INTERVENTION
- label
- Historical
- description
- 40 historical subjects
Primary outcomes (1)
- measure
- Reoperation Rate
- timeFrame
- 2-30 days post Breast Surgery
- description
- Differences in the rate of reoperation due to cancer positive margins
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult female Subject ≥18 years old. * Subject Scheduled for breast conserving surgery of invasive and/or in-situ ductal carcinoma. * Subject is able to read, understand and sign the informed consent. Exclusion Criteria: * Subject previously treated for ipsilateral breast cancer and/or ductal carcinoma in situ surgery. * Subject with previous radiotherapy of the ipsilateral breast. * Subject with multicentric/multilateral breast cancer. * Subject with planned mastectomy, tumor-adapted breast reduction. * Subject with pre-surgical/ preoperative neo-adjuvant treatment. * Subject 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.