Clinical trial · Interventional
Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery.
A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.
NCT05113927CI-TRIAL-00117787RCTcompletedN/AResults postedClinicalTrials.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 multi-center, randomized, two-arm study designed to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.
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 |
|---|---|---|---|
| Selene | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Lumpectomy with usual intraoperative margin assessment
- type
- EXPERIMENTAL
- label
- Device
- description
- Imaging of all margins with investigational device
- interventionNames
- Device: Selene
Primary outcomes (1)
- measure
- Participants With at Least One Unaddressed Positive Margin
- timeFrame
- Index Surgery (Baseline timepoint for intraoperative margin assessment) until receipt of final ground truth histopathology report (Approximately 3-7 days post Index Surgery)
- description
- This endpoint is a within-subject comparison of the occurrence of at least one unaddressed positive margin following standard of care (SOC) alone versus after the adjunctive use of the device (SOC + Device). An "unaddressed margin" is an actionable margin where the surgeon could have excised additional tissue but which is determined to be positive by pathology. Positive margin criteria follow NCCN and SSO/ASTRO guidelines: "ink on tumor" for invasive carcinoma and \< 2 mm for DCIS.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age 18 years or older * Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal and/or ductal carcinoma in situ * May include subjects treated with neo-adjuvant therapy (endocrine and/or chemotherapeutic), but not required for study inclusion * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Male * Metastatic cancer (Stage IV) * Lobular carcinoma as primary diagnosis * Previous ipsilateral breast surgery for benign or malignant disease within two years (this includes implants and breast augmentation) * Subjects with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen * Subjects with bilateral disease (diagnosed cancer in both breasts) * Participating in any other investigational margin assessment study which can influence collection of valid data under this study * Use of cryo-assisted localization * Currently lactating * Current pregnancy * Subjects for whom the specimen margins have been destroyed, damaged, or are otherwise not intact prior to imaging (device arm only) imaging
References
Publications (0)
Data not yet available
No reference posted for this study.