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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04360616
• Other study ID #: US-MAM
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2022
• Source: The First Affiliated Hospital of the Fourth Military Medical University
• Contact: Hongping Song, MD
• Phone: 86 029 84771663
• Email: song.hp[@]foxmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1277
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• imaging
perform US and mammography examination

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of the Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

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