Status:
UNKNOWN
The Diagnosis and Prognosis of Nonpalpable Breast Cancer Detected by the US vs Mammography: a Clinical Noninferiority Trial.
Lead Sponsor:
The First Affiliated Hospital of the Fourth Military Medical University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
To evaluate and compare the sensitivity, specificity, AUC, pathology results of core needle biopsy and surgical pathology results coincidence rate, tumor staging, and DFS (disease-free survival) of US...
Eligibility Criteria
Inclusion
- Women aged 18 years and over with full capacity for civil conduct;
- Breast imaging examination (including mammography and breast ultrasound) found that patients with BI-RADS 4 or nonpalpable lesion need to have breast biopsy (refer to the classification of BI-RADS, which is consistent with the indications for biopsy), including some patients with BI-RADS 3 nonpalpable breast lesions who are willing to have biopsy;
- Voluntarily participate in and sign the informed consent form, and be willing to accept the inspection designated by this test;
- The results of blood examination, coagulation examination, preoperative infection examination, and 12 lead ECG examination within 2 weeks before biopsy met the biopsy requirements;
- It conforms to the biopsy standard (refer to the image-guided breast histology biopsy guide in the breast cancer diagnosis and treatment guide and specification of China Anti Cancer Association (2019 version)).
Exclusion
- Women are participating in another clinical trial of drug or medical device;
- Women with neuropsychiatric disorders;
- Women with severe systemic diseases and serious bleeding diseases that can not cooperate with the examination, or the researchers think it is not suitable to participate in this clinical trial;
- Other subjects not suitable for X-ray examination
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
1277 Patients enrolled
Trial Details
Trial ID
NCT04360616
Start Date
April 1 2020
End Date
March 31 2023
Last Update
January 25 2022
Active Locations (1)
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1
The First Affiliated Hospital of Fourth Military Medical University
Xi'an, Shaanxi, China, 710000