Clinical trial · Interventional
Intraoperative Use of an Optical Coherence Tomography (OCT) Imaging System to Guide Additional Margin Cavity Shaves in Breast Conserving Surgery (BCS)
Intraoperative Use of the OTIS™ (OCT Imaging System) to Guide Additional Margin Cavity Shaves in Breast Conserving Surgery (BCS)
NCT04314700CI-TRIAL-00066745terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left the site
Summary
Brief summary (as posted)
Female patients undergoing a breast conserving procedure will be consented for the excised breast tissue to be imaged on an investigational OCT-based device. Additional tissue may be excised to obtain clear/negative margins based on routine standard of care tissue assessment techniques and intraoperative OCT image review.
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 |
|---|---|---|---|
| OCT- based investigational imaging device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- OCT imaging and review of excised breast lumpectomy tissue
- interventionNames
- Device: OCT- based investigational imaging device
Primary outcomes (3)
- measure
- Number of times the surgeon recorded a decision to excise additional tissue based on intra-operative Wide Field Optical Coherence Tomography (WF-OCT) image review in addition to Standard of Care tissue assessment.
- timeFrame
- Within 1 hour of tissue excision
- description
- Surgeon's assessment of margin status post Wide Field OCT (WF-OCT) image review and any action taken, will be recorded.
- measure
- Average time to excise additional tissue during Breast Conserving Surgery (BCS)
- timeFrame
- Within 1 hour of primary tumor excision
- description
- Time taken to excise additional tissue based on WF-OCT image review, will be recorded.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female age 18 or older * Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal or lobular breast carcinoma and/or ductal carcinoma in situ * May include subjects treated with neo-adjuvant endocrine therapy * May include subjects treated with neo-adjuvant chemotherapy with confirmed complete clinical response * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Male * Stage IV breast cancer * Participation in another study that prolongs time to pathologic processing (greater than 1 hour) * Neo-adjuvant treated patients with any chemotherapeutic who have not achieved a complete clinical response * A surgeon makes an intraoperative decision to conduct a frozen section analysis (Any subject-specific data collected from an enrolled subject until the surgeon's intraoperative decision will not be used in the data analysis of this study. These subjects will be replaced in the study and the surgeon's intraoperative decision to conduct a frozen section analysis will be recorded). * Use of cryosurgery * Currently lactating * Current pregnancy * Previous ipsilateral breast surgery for benign or malignant disease in the same quadrant as currently planned surgery
References
Publications (0)
Data not yet available
No reference posted for this study.