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)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasms
• Intervention / Treatment: Diagnostic test: Light-CT

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Houpu Yang, M.D.; Phone Number: +86-10-88324010; Email: yanghoupu@pkuph.edu.cn

Study Locations

• China
  • Beijing, China, 100000
    • Recruiting
    • Beijing Chaoyang Hospital
    • Contact: He Liu, MD
  • Beijing, China, 100000
    • Recruiting
    • Xuanwu Hospital of Capital Medical University
    • Contact: Kaifu Li, MD
    • Principal Investigator: Hua Kang, MD
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Breast Center, Peking University People's Hospital
      • Contact: Houpu Yang, M.D.; Phone Number: 8610-88324010; Email: yanghoupu@pkuph.edu.cn
      • Principal Investigator: Shu Wang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients planning to undergoing breast surgery and breast cancer patient planning to undergoing surgical lymph node staging are eligible for this study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Prior open biopsy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Light-CT; All specimens are detected using Light-CT

Diagnostic test: Light-CT; 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.

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: shu wang, M.D., Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ANTICIPATED): December 12, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: December 31, 2018
• First Submitted That Met QC Criteria: December 31, 2018
• First Posted (ACTUAL): January 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 5, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Breast Neoplasms; Sentinel lymph node; Optical Coherence Tomogram; Dynamic cell imaging
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: LightCT-PKUPH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No