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

NCT04360616 | Unknown FDA Device

• 1 other identifier: US-MAM
• Study Type: observational
• Target: 1,277
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Sensitive

  Proportion of corrected-detected malignant lesions by the US or MG

  3 days

• Specificity

  Proportion of corrected-detected benign lesions by the US or MG

  3 days

• Area under curve

  Area under receiver operating characteristic (ROC) curve in percentage (%)

  3 days

• Disease-free survival (DFS)

  The time that the patient is free of the signs and symptoms of a disease after treatment.

  3 years

Study Arms (2)

MG+

the lesion could detected by mammography

Diagnostic Test: imaging

US+

the lesion could detected by breast ulrtasound

Diagnostic Test: imaging

Interventions

imaging DIAGNOSTIC_TEST

perform US and mammography examination

MG+; US+

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients over 18 years old from China

You may qualify if:

• 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)).

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of the Fourth Military Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fourth Military Medical University

Xi'an, Shaanxi, 710000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hongping Song, MD

  Xijing hospital of The fourth military medical university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongping Song, MD

CONTACT

86 029 84771663; song.hp@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: April 1, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: January 25, 2022

Record last verified: 2022-01

Locations

CN (1)