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

NCT ID: NCT04360616

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1277 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2023-03-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MG+

the lesion could detected by mammography

imaging

Intervention Type: DIAGNOSTIC_TEST

perform US and mammography examination

US+

the lesion could detected by breast ulrtasound

imaging

Intervention Type: DIAGNOSTIC_TEST

perform US and mammography examination

Interventions

imaging

perform US and mammography examination

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of the Fourth Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Song Hongping

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongping Song, MD

Role: PRINCIPAL_INVESTIGATOR

Xijing hospital of The fourth military medical university

Locations

The First Affiliated Hospital of Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongping Song, MD

Role: CONTACT

song.hp@foxmail.com

86 029 84771663

Facility Contacts

hongping song, Ph.D

Role: primary

Songhp@fmmu.edu.cn

+86-29-84771663

Other Identifiers

US-MAM

Identifier Type: -

Identifier Source: org_study_id