Clinical trial · Observational
Real Time Optical Coherence Tomography (OCT) of Human Tissue
NCT01506700CI-TRIAL-00039754terminatedClinicalTrials.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): additional recruitment not needed
Summary
Brief summary (as posted)
This is a single-arm, prospective, study of an optical imaging device on approximately twenty (20) subjects undergoing lumpectomies at one study site. In vivo and ex vivo imaging will be performed on study subjects with results being compared to final pathology.
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 |
|---|---|---|---|
| Optical Coherence Tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The sensitivity and specificity of Optical Coherence Tomography to identify whether or not tumor can be identified ex vivo on breast cancer specimens as compared to post-surgical histology conclusions.
- timeFrame
- One 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 ICF 3. Women who have been histologically diagnosed with invasive ductal carcinoma or invasive lobular carcinoma of the breast prior to surgery 4. Planning breast preservation 5. Patients 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.