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

NCT03791853 | Unknown FDA Device

• 1 other identifier: LightCT-PKUPH
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Neoplasms

Keywords

Breast Neoplasms; Optical Coherence Tomogram; Sentinel lymph node; Dynamic cell imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The lighting feature of different tissue

  Through study completion, an average of 1 year

• Specificity of Light-CT

  One week after the release of the pathological reports.

• Examination time

  Through study completion, an average of 1 year

Study Arms (1)

Light-CT

All specimens are detected using Light-CT

Diagnostic Test: Light-CT

Interventions

Light-CT 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.

Light-CT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Prior open biopsy

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (3)

Breast Center, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Beijing Chaoyang Hospital

Beijing, 100000, China

RECRUITING

Xuanwu Hospital of Capital Medical University

Beijing, 100000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• shu wang, M.D.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Houpu Yang, M.D.

CONTACT

+86-10-88324010; yanghoupu@pkuph.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 3, 2019
• Study Start: April 1, 2018
• Primary Completion: December 12, 2022
• Study Completion: December 31, 2023
• Last Updated: December 21, 2021

Record last verified: 2021-12

Locations

CN (3)