The Diagnosis and Prognosis of Nonpalpable Breast Cancer Detected by the US vs Mammography: a Clinical Noninferiority Trial.

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: imaging

• Registration Number: NCT04360616
• Lead Sponsor: The First Affiliated Hospital of the Fourth Military Medical University

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-detected nonpalpable breast cancer vs mammography-detected nonpalpable breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-22
• Last Update Posted: 2022-01-25
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1277

Inclusion Criteria

1. Women aged 18 years and over with full capacity for civil conduct;
2. 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;
3. Voluntarily participate in and sign the informed consent form, and be willing to accept the inspection designated by this test;
4. The results of blood examination, coagulation examination, preoperative infection examination, and 12 lead ECG examination within 2 weeks before biopsy met the biopsy requirements;
5. 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 Criteria

1. Women are participating in another clinical trial of drug or medical device;
2. Women with neuropsychiatric disorders;
3. 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;
4. Other subjects not suitable for X-ray examination

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
US+	imaging	the lesion could detected by breast ulrtasound
MG+	imaging	the lesion could detected by mammography

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	3 years	The time that the patient is free of the signs and symptoms of a disease after treatment.
Sensitive	3 days	Proportion of corrected-detected malignant lesions by the US or MG
Specificity	3 days	Proportion of corrected-detected benign lesions by the US or MG
Area under curve	3 days	Area under receiver operating characteristic (ROC) curve in percentage (%)

Trial Locations

Locations (1)

The First Affiliated Hospital of Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China