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

• Conditions: Breast Neoplasms
• Interventions: Diagnostic Test: Light-CT

• Registration Number: NCT03791853
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2018-12-31
• Study First Submitted QC: 2018-12-31
• Study First Posted: 2019-01-03
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-05
• Last Update Posted: 2021-12-21
• Primary Completion: 2022-12-12
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Patients planning to undergoing breast surgery/surgical lymph node staging.
• Specimen could be obtained.

Exclusion Criteria

• Prior open biopsy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Light-CT	Light-CT	All specimens are detected using Light-CT

Primary Outcome Measures

Name	Time	Method
Sensitivity of Light-CT	One week after the release of the pathological reports.	The true positive rate measures the proportion of positives that are correctly identified by ultrasound

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Beijing Chaoyang Hospital; 🇨🇳 Beijing, China

Breast Center, Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Xuanwu Hospital of Capital Medical University; 🇨🇳 Beijing, China