Clinical trial · Observational
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
NCT02313116CI-TRIAL-00039565suspendedClinicalTrials.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 intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.
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 |
|---|---|---|---|
| Interferometric Synthetic Aperture Microscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Patients With All Positive/Close Margins Correctly Identified With the Device
- timeFrame
- 1 week after surgery
- measure
- Number of Margins With False Positive Device Readings
- timeFrame
- 1 week after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women 18 years of age or older 2. Signed informed consent form 3. Women who have been histologically diagnosed with carcinoma of the breast prior to surgery 4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure Exclusion Criteria: 1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) 2. Neoadjuvant systemic therapy 3. All T4 tumors 4. Previous radiation in the operated breast 5. Prior surgical procedure in the same quadrant 6. Implants in the operated breast 7. Pregnancy 8. Lactation 9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
References
Publications (0)
Data not yet available
No reference posted for this study.