Clinical trial · Observational
Light-CT in the Diagnosis of Breast Tumor and Lymph Node
Achieving Rapid Diagnosis During Breast Cancer Surgery Using Light-CT (High-resolution Full-field Optical Coherence Tomography and Dynamic Cell Imaging)
- 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)
Intraoperative pathological diagnosis such as frozen section and imprint cytology is not routinely recommended in clinical practice because of time and accuracy concerns. Full-field optical coherence tomography (FF-OCT) is a new optical imaging technique that could generate sectioning tomogram from fresh tissue and provide close-to-pathology depiction of the morphological structure and pathological changes in minutes without conventional tissue preparation, slicing, and staining, and dynamic cell imaging (DCI) added the viability information of cells/tissue, which could be more important in cancer diagnosis. This study was to evaluate the feasibility and diagnostic value of FF-OCT and DCI in breast lesions and lymph node specimens during breast cancer surgery. We evaluated normal breast tissue, benign breast lesions, breast cancer and axillary lymph node specimens resected from patients undergoing breast surgery.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Light-CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Light-CT
- description
- All specimens are detected using Light-CT
- interventionNames
- Diagnostic Test: Light-CT
Primary outcomes (1)
- measure
- Sensitivity of Light-CT
- timeFrame
- One week after the release of the pathological reports.
- description
- The true positive rate measures the proportion of positives that are correctly identified by ultrasound
Secondary outcomes (3)
- measure
- The lighting feature of different tissue
- timeFrame
- Through study completion, an average of 1 year
- description
- By the comparison analysis of FF-OCT and DCI images and corresponding pathological images, lighting feature would be extracted.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients planning to undergoing breast surgery/surgical lymph node staging. * Specimen could be obtained. Exclusion Criteria: * Prior open biopsy
References
Publications (0)
Data not yet available