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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03791853
Other study ID # LightCT-PKUPH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date December 31, 2023

Study information

Verified date December 2021
Source Peking University People's Hospital
Contact Houpu Yang, M.D.
Phone +86-10-88324010
Email yanghoupu@pkuph.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2023
Est. primary completion date December 12, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Patients planning to undergoing breast surgery/surgical lymph node staging. - Specimen could be obtained. Exclusion Criteria: - Prior open biopsy

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Beijing Chaoyang Hospital Beijing
China Breast Center, Peking University People's Hospital Beijing Beijing
China Xuanwu Hospital of Capital Medical University Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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.
Secondary Examination time The time from the specimen preparation to the completion of the examination. Through study completion, an average of 1 year
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