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
|Condition or disease||Intervention/treatment|
|Breast Neoplasms||Diagnostic Test: Light-CT|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|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|
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.
- 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
- 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.
- 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.
- Examination time [ Time Frame: Through study completion, an average of 1 year ]The time from the specimen preparation to the completion of the examination.
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
|Contact: Houpu Yang, M.D.||+email@example.com|
|Breast Center, Peking University People's Hospital||Recruiting|
|Beijing, Beijing, China, 100044|
|Contact: Houpu Yang, M.D. 8610-88324010 firstname.lastname@example.org|
|Principal Investigator: Shu Wang, M.D.|
|Principal Investigator:||shu wang, M.D.||Peking University People's Hospital|