Clinical trial NCT03791853: Light-CT in the Diagnosis of Breast Tumor and Lymph Node
Official title: Achieving Rapid Diagnosis During Breast Cancer Surgery Using Light-CT (High-resolution Full-field Optical Coherence Tomography and Dynamic Cell Imaging)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Keywords: Breast Neoplasms
Optical Coherence Tomogram
Sentinel lymph node
Dynamic cell imaging
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Prior open biopsy

Primary outcomes:
measure: Sensitivity of Light-CT
timeFrame: One week after the release of the pathological reports.
Secondary outcomes:
measure: The lighting feature of different tissue
timeFrame: Through study completion, an average of 1 year
measure: Specificity of Light-CT
timeFrame: One week after the release of the pathological reports.
measure: Examination time
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Breast Center, Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
city: Beijing
country: China
facility: Xuanwu Hospital of Capital Medical University
Study officials:
affiliation: Peking University People's Hospital
name: shu wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: