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

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ClinicalTrials.gov Identifier: NCT03791853
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Peking University People's Hospital

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.

Condition or disease Intervention/treatment
Breast Neoplasms Diagnostic Test: Light-CT

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Achieving Rapid Diagnosis During Breast Cancer Surgery Using Light-CT (High-resolution Full-field Optical Coherence Tomography and Dynamic Cell Imaging)
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Light-CT
All specimens are detected using Light-CT
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.




Primary Outcome Measures :
  1. Sensitivity of Light-CT [ Time Frame: One week after the release of the pathological reports. ]
    The true positive rate measures the proportion of positives that are correctly identified by ultrasound


Secondary Outcome Measures :
  1. The lighting feature of different tissue [ Time Frame: Through study completion, an average of 1 year ]
    By the comparison analysis of FF-OCT and DCI images and corresponding pathological images, lighting feature would be extracted.

  2. Specificity of Light-CT [ Time Frame: One week after the release of the pathological reports. ]
    The true negative rate measures the proportion of positives that are correctly identified by Light-CT.

  3. Examination time [ Time Frame: Through study completion, an average of 1 year ]
    The time from the specimen preparation to the completion of the examination.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior open biopsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791853


Contacts
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Contact: Houpu Yang, M.D. +86-10-88324010 yanghoupu@pkuph.edu.cn

Locations
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China, Beijing
Breast Center, Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Houpu Yang, M.D.    8610-88324010    yanghoupu@pkuph.edu.cn   
Principal Investigator: Shu Wang, M.D.         
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: shu wang, M.D. Peking University People's Hospital

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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03791853     History of Changes
Other Study ID Numbers: LightCT-PKUPH
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Peking University People's Hospital:
Breast Neoplasms
Optical Coherence Tomogram
Sentinel lymph node
Dynamic cell imaging

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases