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

NCT ID: NCT03791853

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms

Keywords

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Breast Neoplasms Optical Coherence Tomogram Sentinel lymph node Dynamic cell imaging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Light-CT

All specimens are detected using Light-CT

Light-CT

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Prior open biopsy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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shu wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Breast Center, Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Chaoyang Hospital

Beijing, , China

Site Status RECRUITING

Xuanwu Hospital of Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Houpu Yang, M.D.

Role: CONTACT

Phone: +86-10-88324010

Email: [email protected]

Facility Contacts

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Houpu Yang, M.D.

Role: primary

He Liu, MD

Role: primary

Kaifu Li, MD

Role: primary

Other Identifiers

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LightCT-PKUPH

Identifier Type: -

Identifier Source: org_study_id