Light-CT in the Diagnosis of Breast Tumor and Lymph Node

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Light-CT, a special-designed pathology-approximation system which is based on the lighting feature or dynamic feature of tissue and cells, is used to detect malignant cells or tissue in fresh specimens. Morphological structure and pathological changes could be captured in minutes, which implies a possible application in intraoperative diagnosis. In this study, fresh breast tissue, fat, benign breast lesions, breast cancer and axillary lymph node specimens are collected to assess the usefulness of Light-CT. During the in vitro examination, both FF-OCT and DCI images are obtained and stored. Imaging analysis would be performed in traditional imaging analysis like manner and an artificial intelligence aided approach as well. In this study, breast and lymph node specimens would be collected and imaged both through light imaging and conventional pathological analysis.

Official Title
-----------------
Achieving Rapid Diagnosis During Breast Cancer Surgery Using Light-CT (High-resolution Full-field Optical Coherence Tomography and Dynamic Cell Imaging)

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Diagnostic Test: Light-CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients planning to undergoing breast surgery/surgical lymph node staging. Specimen could be obtained. Exclusion Criteria: Prior open biopsy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Light-CT<br>All specimens are detected using Light-CT | Diagnostic Test: Light-CT<br>* Fresh specimen is trimmed into a block with a size not larger than 2.5 cm (Typically not larger than 1.5 cm). Prepared specimen is submitted to Light-CT tests. FF-OCT images are obtained to depict the structure information and DCI images are generated to collect the dynamic information of the cell and tissue. After the imaging detection, specimens are submitted for routine pathological diagnosis to obtain corresponding pathological images.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Light-CT | The true positive rate measures the proportion of positives that are correctly identified by ultrasound | One week after the release of the pathological reports. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The lighting feature of different tissue | By the comparison analysis of FF-OCT and DCI images and corresponding pathological images, lighting feature would be extracted. | Through study completion, an average of 1 year | 
| Specificity of Light-CT | The true negative rate measures the proportion of positives that are correctly identified by Light-CT. | One week after the release of the pathological reports. | 
| Examination time | The time from the specimen preparation to the completion of the examination. | Through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Neoplasms, Optical Coherence Tomogram, Sentinel lymph node, Dynamic cell imaging