Clinical trial · Observational
Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.
A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.
NCT04242277CI-TRIAL-00066541completedClinicalTrials.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 is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.
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 Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Investigational WF-OCT device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- WF-OCT imaging of excised breast lumpectomy tissue
- description
- Excised lumpectomy tissue from all consented patients will be imaged on an investigational OCT-based device. No clinical decisions will be made based on the images acquired.
- interventionNames
- Device: Investigational WF-OCT device
Primary outcomes (1)
- measure
- WF-OCT image acquisition of excised lumpectomy tissue margins
- timeFrame
- 1 year
- description
- This is a data collection study. The primary outcome is the collection of WF-OCT images of excised lumpectomy tissue margins.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age 18 years or older * Invasive ductal breast carcinoma and ductal carcinoma in situ having undergone breast conservation surgery * May include neo-adjuvant treated subjects (chemotherapeutic, endocrine therapy, or radiation) * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Metastatic cancer (Stage IV) * Lobular carcinoma as primary diagnosis
References
Publications (0)
Data not yet available
No reference posted for this study.