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

Breast Neoplasms Clinical Trial

Official title:

Achieving Rapid Diagnosis During Breast Cancer Surgery Using Light-CT (High-resolution Full-field Optical Coherence Tomography and Dynamic Cell Imaging)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03791853
• Other study ID #: LightCT-PKUPH
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Breast Neoplasms

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